JOB DESCRIPTION
We are seeking motivated and detail-oriented Design Verification Engineers at various levels 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.
Design Verification Engineer I
Essential Functions:
- Assist in testing activities, including execution of test protocols, troubleshooting, and data collection.
- Participate in requirements review and verification discussions.
- Contribute to writing test protocols under supervision, ensuring compliance with medical device standards.
- Maintain detailed test documentation following good documentation practices (GDP).
- Support the creation of defect logs and anomaly examination reports.
Competencies:
- Basic knowledge of the V-model and requirements traceability matrix.
- Foundational understanding of statistical methods for sample size calculation and data analysis.
- Team player with a collaborative spirit.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Innovative mindset with a focus on practical application.
Design Verification Engineer II
Essential Functions:
- Actively participate in requirements engineering, including requirements creation and review.
- Develop and execute formal test protocols, ensuring alignment with IEC 60601-1, IEC 62304, and other relevant standards.
- Perform statistical sample size calculations and analyze test data for compliance.
- Design test methods and fixtures for verification testing.
- Document test reports, maintain defect logs, and investigate anomalies.
- Troubleshoot and resolve issues that arise during the testing process.
Competencies:
- 2+ years of experience in medical device design verification or a related field.
- Proficiency in the V-model, requirements traceability matrix, and formal protocol writing.
- Strong analytical and problem-solving skills.
Supervisory Responsibility
No
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.
