As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Lead Engineer (Electronics) – direct hire / full time   Reports to: Director of Advanced Manufacturing   Department: Electronics Engineering / Operations   Location: Allen, TX 75002   Summary: The Lead Engineer leads a team of Engineers and Technicians to oversee the smooth and efficient running of the Electronics Manufacturing, and has oversight over each phase of the manufacturing process. He/She establishes systems and practices to encourage workflow improvements to enhance the organization's productivity.   The Lead Engineer also oversees the installation and commissioning of new equipment or technology and ensures that the equipment complies with regulatory requirements, while ensuring the mitigation of risks. He/She ensures that resources are available and trained in the installation, set-up, maintenance, and troubleshooting of the new equipment.   The Lead Engineer has excellent problem solving and analytical skills. He/She has strong leadership and communication skills and is able to carry out negotiations with vendors. He/She also constantly updates his/her understanding of technology and cutting edge methods in the relevant field.   Requirements:

• A bachelor’s degree, preferably in computer or electrical engineering or a related field
• 5 years of experience in engineering, with at least 2 years in a leadership role
• Ability to mentor and guide junior engineers
• Strong technical and problem-solving skills
• Excellent communication and interpersonal skills
• The ability to work effectively in a team environment
• Complex problem-solving and critical thinking skills.
• Working knowledge of Software programming, PC boards design and/or testing a plus.

  Responsibilities:

• Providing technical direction and engineering leadership for a team of engineers
• Oversees the development of others within the area of the incumbent's expertise, including the creation of knowledge transfer documentation materials
• Mentoring and guiding junior engineers
• Contributing to the design and development of new products and features
• Ensuring that engineering processes are followed
• Maintaining product quality
• Managing projects from start to finish by setting deadlines and ensuring that teams are meeting those deadlines
• Identifying problems in existing products or processes and proposing solutions
• Manage and assist in the process to design, develop and test electrical equipment and products.
• Capture and review electrical design requirements and features

  Notables / Benefits:

• Summer hours available
• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 7+ years
• 401k with employee matching available
• Paid vacation, health/dental/vision, and other excellent benefits

  An Equal Opportunity Employer  

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position: Field Service Engineer – full time / direct hire   Summary: Perform customer support activities, both in-house and at the customer site, involving the installation, preventive maintenance and repair of the Quest Medical instrumentation.   Qualifications:

• One or more years of experience in troubleshooting and repair of electronic/electro-mechanical assemblies of medical devices or instruments or equivalent repair and service activity.
• Ability to manage financial responsibilities.
• Ability to travel for extended periods (>50% of time) within the continental US and occasional international travel.
• Ability to work in a teamwork setting and as an individual contributor.
• Experience in dealing with internal and external customers.
• Computer skills using Microsoft Word, Excel, and the ability to work remotely.
• Ability to use standard field service engineer’s tools sets (scope, DMM, DVM).
• Ability to lift up to 65 lbs.

  Preferred Skills:

• ESD Experience
• Soldering experience
• FDA/ISO Regulated environment experience

  Responsibilities:

• Travel to customer location to conduct on-site installation of instrument and follow established testing procedures to ensure proper working order or perform preventive maintenance and upgrades on Quest Medical instruments.
• Isolate instrument malfunctions and take corrective action in the form of repair.
• Ensure all customer and Service instruments are in good working order.
• Represent Quest Medical in dealings with customers and is responsible for customers’ satisfaction with the MPS instrument.
• Support inside service department in processing instrumentation.
• Communicate all service/repair activity with customer (as necessary), Field Service leadership, and other applicable Quest Medical team members.
• Travel approximately 50% of time.
• Provide feedback on improved methodologies for repair and maintenance tasks.

  Notables / Benefits:

• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 7+ years
• 401k with employee matching available
• Paid vacation and other excellent benefits

  An Equal Opportunity Employer    

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: MPS Sales Manager (NE Region) – direct hire / full time   Reports to: Director, MPS Sales   Department: Sales   Region: Maine, New Hampshire, Vermont, Connecticut, Rhode Island, Massachusetts   Summary: An individual with clinical acumen whose primary responsibilities are to sell Quest Cardiovascular products and manage the sales process through technical presentations, customer training, managing business processes, and relationship building.  Drives sales and market shared growth in the assigned territory.  The Sales Manager needs to be experienced in prospecting to generate own opportunities, follow-up, and post-sale account management across MPS and CV product offerings.   Duties:

• Maintain awareness of all cardiac surgery centers, caseloads, cardiac surgeons, and perfusionists within assigned territory. Create and maintain quarterly business containing target accounts and planned dates for activities of sales process.
• Establish relationships with Key Opinion Leaders (KOL’s) within key accounts (GPO’s, IDN’s, Hospitals, etc.) to ensure Sales Goals/Strategies are executed and contract compliance is fulfilled.
• Develop and nurture relationships with key individuals at target accounts, and regularly follow-up with existing customers to maintain good relationships. Develop and leverage each relationship as a strategy to expanding sales opportunities and individual and product credibility.
• Works with sales management to develop and implement working sales plans which include short and long term strategies to maximize market penetration and profitability; initiating and driving sales efforts and performance.
• Meet and exceed annual sales goals.
• Create and sustain a positive image of Quest Medical with all hospital personnel based on technical competence, customer orientation and respect.
• Maintain an excellent working knowledge of Quest product use characteristics, and competitive product/pricing landscape.
• Individually, be responsible for the entire sales process from initial introduction of product through administration approval and closure.
• Identify new applications and product development opportunities.
• Keep up-to-date with market trends, product development, hospital initiatives and drivers and may collaborate inter-departmentally identifying new product/market development. Encourage customer clinical research, presentations and publications, and maintain a good working knowledge of current clinical research related to products.
• Articulate presentations for live or video communications platforms.
• Manage sales activities and notes using CRM tool.
• Prepare weekly, monthly, and quarterly sales reviews as requested by Sales Leadership.
• Willingness and desire to travel. Ability to travel 75% of work time.
• Must attend national sales meetings and trade shows as assigned.

  Requirements:

• Strong drive and desire to succeed and opportunistic mentality toward selling.
• Bachelor’s degree or equivalent experience required; Masters or advanced degree a significant plus.
• Two years of cardiovascular sales and five years of medical product sales experience (preferably in CV). Medical equipment sales preferred.
• Ability to effectively interact in the OR environment.
• Ability to present to large groups
• Strong interpersonal relationship building skills.
• Aptitude, desire and commitment to learn the intricacies of intraoperative myocardial protection expert.
• Must have a current & valid driver’s license.
• Must possess or have access to a well-maintained automobile
• Must be able to acquire necessary hospital credentialing to access hospitals and ORs as part of their job duties

  Notables / Benefits:

• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 7+ years
• 401k with employee matching available
• Paid vacation and other excellent benefits

  An Equal Opportunity Employer  

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Product Marketing Manager   Reports to: CTO   Department: R&D   Location: Allen, TX 75002   Summary: The position is responsible for the strategy, creation, and definition of new product initiatives in key business segments (Cardiovascular, Fluid Management, and Ophthalmology).  The individual will work with customers, KOL’s, and internal stakeholders to develop the strategy that is incorporated into the development of new products.  This position has the responsibility for the identification and collection of customer needs through a variety of internal and external sources.  This position also has the responsibility of participating in early phase product planning activities and providing business justification along with commercialization strategies for product commercialization.   Requirements:

• The successful candidate will have 5+ years of experience
• Bachelor’s degree in Marketing, Business Administration, or a similar field
• Demonstrated experience with new product marketing
• Experience with development of market models, business development, and product development
• Experience with maintaining communication with several groups of people, including product development team members, superiors, and stakeholders

  Duties:

• Conduct market research and analyses for new products and competitive product offerings in Key Business Segments and other new markets
• Participate in industry and professional conferences to gain marketing and clinical understanding key business segments.
• Identify and quantify marketing opportunities with internal team members (R&D, Clinical, Regulatory, and Marketing) to develop product strategies
• Work with / partner with internal resources (R&D, Marketing, and Clinical Services) to define New Product Development strategy
• Validate new product development concepts with market models / forecasts and business cases
• Assess and identify product opportunities
• Collect VOC to assess a new product’s need and viability
• Determining the key features for a new product required to ensure effectiveness within the market
• Develop technical presentations, data sheets, and product demonstrations
• Work with Marketing to develop product technical data sheets, white papers, and competitive literature

  Notables / Benefits:

• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 7+ years
• 401k with employee matching available
• Paid vacation, health/vision/dental, and other excellent benefits

  An Equal Opportunity Employer

Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Quality Engineer I – direct hire / full time (Multiple openings) Reports to: Director, QA/RQ or Quality Systems Manager   Department: Quality   Location: Allen, TX 75002   Summary: Responsible for maintaining and improving the quality management system.  Performs activities to support quality aspects of design and development, manufacture, and post-production of components and finished products.  Conducts Corrective and Preventive Action activities to investigate causes of non-conformance, determine root cause and implements correction actions to eliminate quality problems.  Provides support and leadership to teams focused on CAPA.  Supports supplier quality program by performing audits, managing supplier metrics, and managing supplier correction action plans.  Develops various product tests and conducts data analysis.  Develops qualification test protocols and generates reports as needed.  Provides guidance on engineering projects. Supports the internal and external quality audit program. Uses statistical tools to analyze data, make acceptance decisions, and improve proves capability.   Requirements:

• Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience
• A minimum of 2 years of experience in a quality role in a regulated industry such as medical device or pharmaceutical is preferred.
• Familiarity with FDA Quality System Regulation, MDD, ISO 9001, ISO 13485, and ISO 14971 is preferred
• Strong unbiased advocate of compliance
• Ability to work efficiently in a team environment
• Must possess technical writing, project management, and fundamental problem-solving skills
• Experience using word processing, spreadsheet, data management and/or design of experiments
• Prior experience in auditing is desired
• Previous experience performing laboratory and/or mechanical testing required
• Excellent strong verbal and written communication skills
• Ability to travel up to 10% of the time

  Responsibilities:

• Support daily manufacturing activities and work with Engineers to resolve line issues and implement corrective actions.
• Provide technical support for incoming inspection and lot release testing activities.
• Provide support and leadership to Product Improvement Teams as Quality Engineer.
• Manage customer complaint investigations from initiation through investigation and closure. Ensure reportability assessments are made in a timely manner for each complaint.  Ensure quality, in-depth investigations are performed, including effective root cause and corrective action assessments.
• Manage NCMR investigations from initiation through investigation and closure. Perform product dispositions in a timely manner.  Ensure quality, in-depth investigations are performed, focusing on elimination of the defect condition through effective root cause and corrective action problem solving techniques
• Provide input to the Supplier Quality program by evaluating potential suppliers, managing supplier corrective actions, performing supplier audits, and evaluating quality metrics.
• Support the Internal Audit program by auditing, identifying and correcting deficiencies, creating reports, and conducting verifying effectiveness of corrective actions
• Provide quality engineering support to engineering project teams associated with new product development projects or process improvement projects
• Revise quality system procedures (SOPs and WIs)
• Write protocols and coordinate the testing for validation activities, component qualification activities, IQ/OQs, test method validations, and Gage R&R studies.
• Develop and maintain risk management files and quality control plans for components, devices and processes.
• Provide training and/or technical guidance to QA Technicians and production staff as required.
• Uses statistical analyses and interpretations for investigations, specification setting activities, and test protocols.
• Participate in inspections with FDA, ISO, MDD, MDSAP and other regulatory agencies.
• Support major quality projects which result in CPAR files
• Use effective problem solving techniques to support successful completion of job duties.
• Strive to constantly innovate and implement improvements for improved methods for testing components.
• Works under general supervision. Relies on instructions and pre-established guidelines to perform the functions of the job.

  Notables / Benefits:

• Summer hours available
• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 7+ years
• 401k with employee matching available
• Paid vacation, health/dental/vision, and other excellent benefits

  An Equal Opportunity Employer  

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: MPS Sales Manager (TX Region) – direct hire / full time   Reports to: Director, MPS Sales   Department: Sales   Summary: An individual with clinical acumen whose primary responsibilities are to sell Quest Cardiovascular products and manage the sales process through technical presentations, customer training, managing business processes, and relationship building.  Drives sales and market shared growth in the assigned territory.  The Sales Manager needs to be experienced in prospecting to generate own opportunities, follow-up, and post-sale account management across MPS and CV product offerings.   Duties:

• Maintain awareness of all cardiac surgery centers, caseloads, cardiac surgeons, and perfusionists within assigned territory. Create and maintain quarterly business containing target accounts and planned dates for activities of sales process.
• Establish relationships with Key Opinion Leaders (KOL’s) within key accounts (GPO’s, IDN’s, Hospitals, etc.) to ensure Sales Goals/Strategies are executed and contract compliance is fulfilled.
• Develop and nurture relationships with key individuals at target accounts, and regularly follow-up with existing customers to maintain good relationships. Develop and leverage each relationship as a strategy to expanding sales opportunities and individual and product credibility.
• Works with sales management to develop and implement working sales plans which include short and long term strategies to maximize market penetration and profitability; initiating and driving sales efforts and performance.
• Meet and exceed annual sales goals.
• Create and sustain a positive image of Quest Medical with all hospital personnel based on technical competence, customer orientation and respect.
• Maintain an excellent working knowledge of Quest product use characteristics, and competitive product/pricing landscape.
• Individually, be responsible for the entire sales process from initial introduction of product through administration approval and closure.
• Identify new applications and product development opportunities.
• Keep up-to-date with market trends, product development, hospital initiatives and drivers and may collaborate inter-departmentally identifying new product/market development. Encourage customer clinical research, presentations and publications, and maintain a good working knowledge of current clinical research related to products.
• Articulate presentations for live or video communications platforms.
• Manage sales activities and notes using CRM tool.
• Prepare weekly, monthly, and quarterly sales reviews as requested by Sales Leadership.
• Willingness and desire to travel. Ability to travel 75% of work time.
• Must attend national sales meetings and trade shows as assigned.

  Requirements:

• Strong drive and desire to succeed and opportunistic mentality toward selling.
• Bachelor’s degree or equivalent experience required; Masters or advanced degree a significant plus.
• Two years of cardiovascular sales and five years of medical product sales experience (preferably in CV). Medical equipment sales preferred.
• Ability to effectively interact in the OR environment.
• Ability to present to large groups
• Strong interpersonal relationship building skills.
• Aptitude, desire and commitment to learn the intricacies of intraoperative myocardial protection expert.
• Must have a current & valid driver’s license.
• Must possess or have access to a well-maintained automobile
• Must be able to acquire necessary hospital credentialing to access hospitals and ORs as part of their job duties

  Notables / Benefits:

• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 7+ years
• 401k with employee matching available
• Paid vacation and other excellent benefits

  An Equal Opportunity Employer

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Quality Operations Engineer I – direct hire / full time   Reports to: Quality Operations Manager   Department: QA/RA   Location: Allen, TX 75002   Summary: We are seeking a highly skilled Quality Engineer to ensure the development, manufacture, procurement, and acceptance of high-quality products and assemblies. The successful candidate will be responsible for participating or leading teams, coordinating product acceptance equipment design, monitoring quality metrics, analyzing discrepancies, and developing test procedures utilizing Six Sigma methodology. This person will also provide technical consultation, improve product quality, and ensure adherence to industry standards.   Requirements:

• Bachelor of Science degree in a technical area such as science, engineering, math or equivalent experience. Can be fulfilled by the sufficient years of relevant work experience.
• 3 to 5 years of manufacturing experience.
• Ability to work well on a team and has a cooperative attitude.
• Knowledge in MDSAP, FDA Quality System Regulation, MDD, and/or ISO 13485.
• Must possess technical writing, project management and fundamental problem-solving skills.
• Excellent writing and communication skills. The individual should be detail oriented and have good deductive and problem-solving skills.
• Self-motivated employee that does not need to receive direct supervision to carry out day to day activities.
• Familiar with current quality methodology, such as Six Sigma, FMEA, statistics analysis, sampling, DOE, capability studies.
• Experience in using quality engineering techniques, including experience writing procedures and developing standards for new processes.
• Proficient in Microsoft Office applications and statistical analysis software.
• Experience in ERP software
• Environmental Monitoring and Cleanroom Standard experience is a plus.

  Responsibilities:

• Participates or leads teams to provide quality input for the development, manufacture, procurement, and acceptance of a variety of products and assemblies.
• Develops and monitors quality metrics, levels, and trends.
• Provide inputs into and ensure the outputs from Material Review Board activity and Non-Conforming Material Reports (NCMR) are being executed on a timely basis, including re-inspection and QC disposition activities.
• Develops test procedures and performs evaluation tests, capability studies, quality audits, data reviews, and other engineering evaluations utilizing Six Sigma methodology.
• Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
• Communicates significant issues or developments identified during quality assurance activities and provides recommended process improvements to management.
• Lead/participate in projects to ensure the health of the Quality Operations group, as well as the Quality Assurance Department as a whole. This projects may be dictated by management or self-identified projects.
• Administrate the Environmental Monitoring Program, including the performing of any tests and submitting necessary test samples to laboratory to ensure compliance to internal procedures.
• Work to improve all aspects of quality control inspections, especially efficiency and cost reduction when applicable. This includes sourcing new equipment to perform inspections, methodologies of inspections, and streamlining the inspection process.
• Use project management tools to calculate estimated time for performing a series of tests within the normal inspection process. Make recommendations about procedures for optimizing the testing process.
• Make necessary updates to controlled documentation in order to facilitate continuous improvement in all aspects of the Quality Control process.
• Write technical reports associated with qualifications, quality improvements and CAPA projects.

  Notables / Benefits:

• Summer hours available
• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 7+ years
• 401k with employee matching available
• Paid vacation, health/dental/vision, and other excellent benefits

  An Equal Opportunity Employer

As a part of the team, you will be contributing to each of our core beliefs: Empowerment, Innovation, Speed & Purpose, Teamwork & Collaboration, Growth, and Fun. You will be empowered to ensure we are producing high quality products that meet the standards of our regulatory bodies and our customers.   Quest Medical, Inc. is a US based manufacturer that develops and manufactures sterile medical devices for a variety of medical markets. Those markets include cardiac surgery, ophthalmic surgery, oncology, IV fluid, and anesthesia delivery. Our company culture is very diverse and the average tenure for our employee population is 7+ years. If you are looking for a stable and successful company where your voice will be heard, Quest is the place to be.   Position Title: Senior R&D Engineer – direct hire / full time   Reports to: Director, R&D Engineering   Location: Allen, TX 75002   Summary: The Senior R&D Engineer will design and develop new products within the existing product portfolio (Cardiac Surgery, Ophthalmology, and IV Therapy) as well as new markets for Quest Medical.  The Senior R&D Engineer will be the technical engineering leader for all aspects from conception through commercialization of these products and will be expected to lead a cross-functional team to ensure all phases of the design controls process are delivered within project timelines and budgets.  The Senior R&D Engineer will also be responsible for identifying and leading front-end development for new product discoveries to promote future growth for the organization.   Requirements:

• Bachelor of Science degree in a technical field such as biomedical engineering, polymer science, chemistry, chemical engineering, mechanical engineering, or other engineering field is required.
• Minimum of 8-10 years of experience in design and development of products with project management experience. Applicants with an advanced degree in the above technical fields may be considered with lesser experience.
• Demonstrated ability to identify, explore, and vet new product opportunities.
• Project management experience and knowledge of design control processes and QSR.
• Broad knowledge/experience with design for manufacturing and common manufacturing/fabrication processes including, but not limited to, injection molding, sheet metal, extrusion, solvent bonding, ultrasonic welding, RF forming/welding, thermoforming, pad printing, and other relevant medical device processes.
• Extensive knowledge of mechanical component, part and assembly design and fabrication. Working knowledge of electrical design is a plus.
• Ability to communicate effectively at all levels of personnel, both internally and externally.
• Computer literate and ability to use major software tools including proficiency with CAD programs (SolidWorks preferred). Knowledge of statistical techniques.
• Possess above average technical writing, analytical, and communication skills. Ability to communicate complex problems for understanding to non-technical personnel. Ability to effectively communicate with clinicians and health professionals in the field.
• Must demonstrate initiative and require minimal supervision. Self-starter with results driven characteristics.
• Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.
  • Knowledge of Good Lab practices equipment and hazards, upkeep, and handling of biologic mediums.

  Duties:

• Execute front-end research & development for new products including clinical research, market research, competitive benchmarking, product conception and prototyping, feasibility and opportunity appraisal.
• Lead creation of customer and product requirements and specifications.
• Ability to develop and communicate understanding of clinical needs, product opportunities, and technology direction to project team.
• Support marketing and clinical assessment on new products and concept initiatives. Define unmet needs and clinical pathway to address device opportunities.
• Analyze the competitive landscape, customer and market trends, and product requirements as part of new product development processes.
• Support collaborative ideation through concept development, prototyping, and feasibility studies.
• Detailed design activities including 3D modeling and develop technical drawings, data sheets, and schematics.
• Supports design for manufacturing activities including final part/assembly design, manufacturing process design, manufacturing assembly procedures and manufacturing testing procedures.
• Participates in the safety hazard/risk analysis on products/systems, collaborating with the risk manager and other engineering disciplines.
• Perform design verification and validation activities which meet all necessary requirements of a project, including drafting qualification documents ranging from equipment qualification to product validation.
• Understand and execute all aspects of Design Controls during product and/or process development projects.
• Understand quality system requirements of customers, FDA, QSR, and other regulatory agencies, and use quality tools to improve processes and products within those standards.

• Design and implement test and simulation instrumentation, equipment, and procedures, utilizing the principles of engineering and biomedical sciences in development of medical devices related to Cardiovascular Surgery, Ophthalmology, Infusion Therapy, and other applicable markets.
• Advise and assist in the application of instrumentation in clinical environments to support existing product lines and new product development.
• Select and develop appropriate test tools, applying the latest techniques in testing and verification e.g., data-driven testing and clinical simulations.
• Participate in the Change Management process to identify the quality implications and impact of proposed changes to product performance via the testing process.
• Coordinate and lead project design reviews with emphasis on gap/risk analysis to ensure projects meet predetermined goals and objectives.
• This individual will be part of a larger product development team and/or lead a small/moderate product development team based on complexity and skill sets.
• This individual will be expected to solve technical issues and resolve problems/delays associated with projects with minimal supervision from Manager.
• Competencies and knowledge of time, task and project management will be necessary to provide cross functional team with accurate and precise estimates for assigned task duration, along with confidence levels and foreseeable dependencies.
• Assist the Manager in preparing project plans, budgets, and schedules.
• Provide technical guidance to technicians, interns, and cross-functional team members assigned to product and process activity relating design, testing, and documentation.
• Support design transfer and commercialization activities and provide training for SMEs to sustain new product releases/

  Notables / Benefits:

• Summer hours available
• Mid-size company with great company culture that is well diverse
• Have a voice in the company
• Average tenure for employee population is 7+ years
• 401k with employee matching available
• Paid vacation, health/vision/dental, and other excellent benefits

  An Equal Opportunity Employer