Develop documentation such as URS, mechanical / electrical drawings, SOPs, and contribute to QMS requirements.
Partner with cross‑functional teams to support product development, manufacturing operations, and issue resolution.
Lead continuous improvement initiatives focused on safety, quality, and efficiency.
Qualifications
BS or advanced degree in Mechanical Engineering or related field.
6–10+ years of experience developing, installing, qualifying, and maintaining automated systems in high‑volume medical device manufacturing.
Hands‑on experience creating and executing IQ / OQ / PQ protocols.
Skilled in developing URS, FAT, and SAT documentation for automated equipment.
Proficient in 3D CAD (SolidWorks or similar) and mechanical design of fixtures, assemblies, and equipment.
Strong grasp of mechanical systems, manufacturing processes, and DFM principles.
Excellent project / time management and consistent on‑time delivery.
Proven problem‑solving skills and ability to work both independently and within cross‑functional teams.
Self‑driven, adaptable, and motivated to contribute to impactful work in human health.
Seniority level
Associate
Employment type
Full‑time
Job function
Engineering and Science
Industries
Engineering Services and Biotechnology Research
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