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Salary: USD 130,000 - 147,000 / annual
Kestra Medical is a medical device company founded in 2014 that combines wearable technologies with proven cardiac device therapies. The company has over 400 years of collective experience in external and internal cardiac medical device markets.
This Senior Mechanical Verification Engineer role reports directly to the Electrical Engineering Manager and leads the Design Verification function for research and development projects supporting the company's long-term strategic vision. You will be responsible for design verification and qualification across multiple project phases, coordinating resource and timing needs, driving process and quality improvements within the design verification organization and product development process, and providing technical leadership to the department.
Key responsibilities include:
- Reading and interpreting medical device standards (safety, essential performance, EMC, FCC) to ensure test protocols achieve compliance
- Developing verification and qualification test protocols for system, hardware, and component-level requirements
- Creating verification plans and reports with full traceability to allocated requirements
- Performing system, hardware, and qualification tests with accurate and complete documentation
- Designing, constructing, and documenting test fixtures to support verification activities
- Operating lab equipment including 3D printers, laser cutters, drill press, mill, twist and flex apparatus, data acquisition systems, and electrical test equipment (DMMs)
- Performing statistical analysis of test results to ensure confidence and reliability requirements are met
- Driving continuous improvement initiatives and collaborating across all organizational levels
You will work in an indoor open office and lab environment with occasional domestic and international travel (less than 20%).
QUALIFICATIONS:
Required: B.S. in Engineering or related science field; minimum 5 years of related experience; mechanical engineering knowledge with proficiency in 3D modeling and design; quality systems knowledge and design verification experience; medical device experience, QSR regulation experience, and manufacturing/operations experience; strong passion for improving product and process quality and reliability; strong verbal, written, and interpersonal communication skills with influencing capability; strong decision-making and judgment skills.
Preferred: M.S. in engineering or industrial science; Six Sigma or Lean Sigma experience; knowledge of FDA Quality System Regulations and OUS Quality System Regulations.
