FullTime
Allen, TX
Posted 2 weeks ago

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 10+ 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 Systems Engineer – direct hire / full-time

 

Reports to:

Director, Engineering & Maintenance

 

Department:

Manufacturing Engineering – Electronics

 

Location:

Allen, TX 75002

 

Summary:

The Senior Systems Engineer will be the supporting sustaining engineer who understands the full interaction of the mechanical, electrical, and software elements of the MPS console.  Software development with an emphasis on structured software design and coding and system integration of HW-SW. High degree of autonomy and utilization of current development tools and processes. Utilize technical expertise and Engineering skills to develop safe and effective medical products and take these products from concept, through manufacturing to market.  Work with all corporate departments to sustain products and ensure product quality.

 

Requirements:

  • Bachelor’s degree or higher, preferably in computer engineering, electrical engineering, a physical science or engineering.
  • Experience in real-time embedded software development preferably in the Medical device industry. Knowledge of at least one formal software modeling procedure, “C” and “C++”. Working knowledge of compilers, linkers, debuggers, emulators and version control systems required.
  • Good writing, analytical, and communication skills.
  • Capable of creative design work with minimal supervision in an engineering environment. Advanced LabVIEW skills is a plus.
  • Thorough understanding of FDA Quality System Regulations, ISO 13485. Experience in a Regulated industry is required.
  • Familiarity with industry standards related to development lifecycle, verification & validation procedures and Risk analysis & mitigation techniques are preferred.
  • Effective interfacing with electrical and mechanical engineers to develop and sustain products.
  • Basic knowledge of QSR, Design Control, and Design Verification and Validation.
  • Good writing, analytical, and communication skills.
  • Capable of sustaining engineering and product improvement work with minimal supervision in an engineering environment.
  • Familiarity with statistical techniques, mathematical analysis and software modeling.
  • Effective interfacing with electrical and mechanical personnel as well as other corporate groups.
  • Ability to communicate complex problems for understanding to non-technical personnel.
  • Detail oriented and ability to organize large amounts of work and data. This includes the need for good documentation practices.

 

Responsibilities:

  • Recognize the need for quality improvements, system-level troubleshooting of customer feedback, system level improvements on first pass yield on the manufacturing floor, and long-term product design improvement projects. All are long-term needs of Quest Medical.
  • Working within a multidisciplinary team to develop software specifications and test protocols
  • Participate or lead Requirements Specifications in the development of the Product or Systems Requirements Documents.
  • Support the development of a Product or Systems Concept Document as part of the Product Concept team. Design, support and critique the User Interface Design.
  • Deliver high-quality code, according to specifications
  • Deliver high-quality design documentation according to medical regulations
  • Perform tests, code reviews, and other quality assurance tasks
  • Fast prototyping in support of proof of principle activities
  • Carrying out specific project tasks within the timescales and budgets agreed with the project manager.
  • Develop process flow charts, state diagrams, transition diagrams or any other applicable documentation means to define the software design.
  • Participate in Design reviews to improve the design and perform Risk analysis as needed.
  • Write embedded code utilizing structured software development techniques. Use debuggers or other tools to debug the code.
  • Design white box and black box testing as needed to verify and validate the design.
  • Create and execute software design Verification & Validation protocols and reports.
  • Design & execute laboratory procedures when developing new technologies and/or algorithms.
  • Plan, track and report progress of ongoing projects.

 

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 10+ years
  • 401k with employee matching available
  • Paid vacation, health/dental/vision, and other excellent benefits

 

 

An Equal Opportunity Employer

Job Features

Job Category

Engineer

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