Sr Mechanical Verification Engineer

Kestra Medical Technologies Inc.•Kirkland, WA

1d•$130,000 - $147,000

About The Position

The Senior Mechanical Verification Engineer is responsible for the Design Verification function at Kestra and reports directly to the Electrical Engineering Manager. The role leads design verification and qualification for research and development projects supporting the company’s long-term vision and strategic plan. It coordinates resources and timing for development and support projects, drives process and quality improvements within the design verification organization and Product Development Process (PDP), and provides leadership to the department and business. The engineer interprets medical-device safety and essential-performance standards, as well as EMC and FCC standards, and develops protocols, plans, and reports with traceability to allocated requirements. The role performs system, hardware, and qualification testing; maintains complete and accurate test records; and designs, constructs, and documents test fixtures. It also uses laboratory equipment and works across organizational levels to meet objectives.

Requirements

Bachelor of Science in Engineering or a related science field.
At least 5 years of related experience.
Mechanical engineering knowledge and proficiency in 3D modeling and design.
Knowledge of quality systems and experience with design verification.
Medical experience, QSR regulation experience, and manufacturing or operations experience.
Strong commitment to improving product and process quality and reliability.
Strong verbal, written, interpersonal communication, and influencing skills.
Strong decision-making and judgment skills.
Ability to work independently with minimal supervision and seek improved methods.
Expertise in the profession and industry best practices.
Ability to write clear documents that other team members can readily understand and follow.
Ability to perform statistical analysis of test results to assess confidence and reliability requirements.
Ability to collaborate within a team and across functions.
Ability to identify relevant facts and resolve issues effectively.
Flexibility in a fast-paced, goal-oriented environment, with the ability to meet deadlines and accomplish goals.

Nice To Haves

Master’s degree in engineering or industrial science.
Six Sigma or Lean Sigma experience.
Knowledge of FDA Quality System Regulations and OUS Quality System Regulations.

Responsibilities

Interpret medical device standards for safety and essential performance to develop compliant test protocols.
Interpret EMC and FCC standards to develop compliant test protocols.
Develop verification and qualification test protocols for system-, hardware-, and component-level requirements.
Develop verification plans and reports that provide traceability to all allocated requirements.
Perform system, hardware, and qualification tests and ensure test records are accurate and complete.
Use laboratory equipment, including 3D printers, laser cutters, a drill press, a mill, twist and flex apparatus, data acquisition systems, and basic electrical test equipment such as DMMs.
Design, construct, and document test fixtures needed to support verification tests.
Carry out continuous improvement activities as defined by goals and objectives.
Work with all levels of the organization to ensure objectives are met.
Coordinate resource and timing needs for development and support projects.
Drive process and quality improvements within the design verification organization and the PDP process.