Key Responsibilities
- Build, assemble, and troubleshoot complex electromechanical and/or biomedical device prototypes.
- Execute and document design verification and validation (DV&V) testing in accordance with approved protocols.
- Collaborate with engineers to refine designs, identify failure modes, and implement design improvements.
- Develop and maintain test methods, fixtures, and equipment for repeatable and reliable data collection.
- Support risk management activities, including hazard analysis and mitigation verification.
- Generate, review, and maintain detailed technical documentation in compliance with design control requirements (e.g., protocols, reports, test records).
- Ensure all work complies with applicable regulatory standards (e.g., FDA QSR, ISO 13485).
- Assist with root cause investigations and corrective/preventive actions (CAPA).
- Support technology transfer activities to manufacturing, including process development and documentation.
- Maintain lab equipment, calibration records, and inventory of materials and components.
- Mentor junior technicians and provide technical guidance as needed.
Education & Experience
- Associate’s or Bachelor’s degree in Engineering Technology, Biomedical Engineering, or related field.
- 5+ years of hands-on experience in medical device R&D, preferably with Class III devices.
Technical Skills
- Proficiency in mechanical assembly, electrical systems, and/or laboratory testing.
- Experience with test equipment (e.g., oscilloscopes, multimeters, environmental chambers, mechanical test systems).
- Ability to interpret engineering drawings, schematics, and specifications.
- Familiarity with statistical analysis and data interpretation.
Regulatory & Quality Knowledge
- Strong understanding of FDA regulations (21 CFR Part 820) and ISO 13485.
- Experience working under design controls and documentation requirements.
- Knowledge of risk management practices (e.g., ISO 14971) is a plus.
Soft Skills
- Strong attention to detail and organizational skills.
- Effective communication and collaboration across cross-functional teams.
- Ability to manage multiple priorities in a fast-paced, regulated environment.
- Problem-solving mindset with a proactive approach to challenges.