JOB DESCRIPTION
We are seeking a motivated and detail-oriented Senior Design Verification Engineer to join our respiratory device team. The Design Verification Engineer ensures that medical devices meet rigorous safety and efficacy standards by conducting thorough verification testing and documenting results in compliance with industry and regulatory standards, such as IEC 60601-1 and IEC 62304.
The role requires a strong foundation in verification processes, statistical analysis, and protocol development to provide evidence that designs meet their intended requirements. It also plays a critical part in various stages of product development, bridging the design phase with establishing clear design inputs and then testing against those inputs, following formal FDA guidelines. The ideal candidate will have a passion for understanding complex systems, challenging the designs to confirm robustness, completeness, and correctness while collaborating across departments to bring cutting-edge medical devices to life.
As the engineer progresses through job levels, they will take on increasing responsibilities in leadership, technical expertise, and cross-functional collaboration.
Senior Design Verification Engineer
Essential Functions:
- Lead verification activities and take ownership of deliverables, including protocols, reports, and logs.
- Supervise and mentor junior engineers in test execution, troubleshooting, and documentation.
- Collaborate with cross-functional teams to ensure design inputs are verifiable and meet FDA requirements.
- Develop and validate new test methods and fixtures.
- Perform statistical analyses and ensure proper sample size calculations for all verification activities.
- Conduct detailed investigations into anomalies, defects, and failures, ensuring timely resolution.
Competencies:
- 5+ years of experience in design verification for medical devices.
- Expertise in statistical methods and advanced data analysis.
- Demonstrated leadership skills and experience supervising technical teams.
- Deep understanding of IEC 60601-1, IEC 62304, and other relevant standards.
Supervisory Responsibility
Yes
Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and audio/visual equipment.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to sit; use hands to finger, handle or feel objects, tools or controls and talk or hear. The employee is occasionally required to stand, walk, stoop, kneel, crouch or crawl. Specific vision abilities required by this job include close vision and the ability to adjust focus.
Travel
- Ability to travel up to approximately 20%, including internationally.
Required Education and Experience
- Biomedical Engineering, Computer Science, Computer Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
Additional Eligibility Qualifications
None required for this position.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
CAIRE is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.
