Gallin Associates

CLIENT CANNOT SPONSOR/TRANSFER WORK AUTHORIZATION RELOCATION ASSISTANCE Our client is a leading medical device developer focused on biologics and regenerative medicine applications and in growth-mode! This role will lead product design and development projects of new medical devices. REQUIREMENTS: BS degree in Biomed Eng or related discipline 5+ years of R&D experience developing medical devices, ideally class II+ implantables or related Solid, demonstrated experience developing devices from concept stage through commercial release. Strong Device Design Control and Risk Management Biocompatibility research and testing experience is ideal Understanding and experience with Design Control and V&V

CLIENT CANNOT TRANSFER/SPONSOR WORK AUTHORIZATION RELOCATION ASSISTANCE Growing medical device manufacturer seeks a hands-on Manufacturing Engineer to support process development and improvement. Key responsibilities include equipment validation (IQ/OQ/PQ), process troubleshooting, tooling/fixture design, and Six Sigma-based capability improvements. Will support existing and new product introductions. Requirements: BS in Engineering required (Plastics, Chemical, or Mechanical preferred) 3+ years in a manufacturing environment Demonstrated experience driving manufacturing process improvement. Experience in plastic manufacturing processes, ideally extrusion

CLIENT CANNOT SPONSOR/TRANSFER WORK VISA AUTHORIZATION RELOCATION ASSISTANCE PROVIDED Sr. Quality Engineer supporting products from R&D stage (design assurance/design control) through manufacturing (CAPAs/NCM, CI initiatives) for medical devices. Broad cross-organization interaction with project leadership responsibilities. REQUIREMENTS: B.S. degree, preferably in an engineering discipline 6+ years experience, ideally in Medical Devices (implantables highly desired) Demonstrated experience leading cross-functional projects Strong data-driven acumen to drive problem-solving Experience as a Quality Engineer highly desired