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:

R&D Engineer II

Reports to:

Director, R&D Engineering

Location:

Allen, TX 75002

Summary:

The R&D Engineer II 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 R&D Engineer II/III will be the project leader for 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 R&D Engineer II/III will also be responsible for the technical design and engineering of the products ensuring that all requirements are met.  Additionally, this individual will also be expected to participate in ongoing sustaining engineering projects and CAPA projects to provide technical support, as required.

Duties:

• 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 Control 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.
• Proactively address and work with Manager on daily issues associated with GMP, Safety and enhancing testing infrastructure at Quest.

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 4 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.
• Project management experience and knowledge of design control processes and QSR.
• Extensive knowledge of mechanical component, part and assembly design and fabrication. Working knowledge of electrical design is a plus.
• Broad knowledge/experience with 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.
• Ability to communicate effectively at all levels of personnel.
• 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.

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