R&D Scientist/Engineer II, Implantable Medical Devices

Regenity Biosciences; Oakland (NJ); Sur place; USD 85 000 - 95 000; Plein temps

Avantages offerts par ce poste

401(k) plan with company contribution

Paid time off

Medical, prescription, dental, andvis

Company‑paid life and AD&D insurance

Wellness Program

Tuition Reimbursement

Résumé du poste

Regenity Biosciences is seeking an R&D Scientist/Engineer II to drive the design, development, and improvement of implantable regenerative medical devices from concept through commercialization.

You will apply engineering and scientific principles to support product innovation while ensuring compliance with design control and quality system requirements, working independently to support both strategic and operational objectives.

Qualifications

• Requires DHF, V&V, and design control experience.
• Experience with biomaterial characterization and data analysis.
• Familiarity with ISO 13485, 21 CFR Part 820, and ISO 14971 is preferred.

Responsabilités

• Independently contribute to implantable regenerative medical devices in compliance with design control.
• Execute and document design inputs/outputs, risk management, verification, validation, and design transfer.
• Design and conduct experiments, including feasibility studies and prototype fabrication.
• Analyze data to support product development decisions.
• Collaborate with Quality, Regulatory, Manufacturing to ensure compliance and timely project execution.

Connaissances

Design control

V&V

Biomaterial characterization

Data analysis

Independent work

CAD software

Formation

Bachelor's degree in related field

Master's degree

Outils

CAD software

Prototyping tools

Modeling software

Description du poste

Regenity Biosciences is seeking an R&D Scientist/Engineer II to drive the design, development, and improvement of implantable regenerative medical devices from concept through commercialization.

You will apply engineering and scientific principles to support product innovation while ensuring compliance with design control and quality system requirements, working independently to support both strategic and operational objectives.