Mechanical Engineer - Implantable Drug Delivery Systems

Vivani Medical, Inc-posted 3 months ago
$140,000 - $175,000/Yr
Full-time • Mid Level
Alameda, CA
Resume
Match Score
Upload and Match ResumeTrack Jobs with Teal

We are seeking a detail-oriented Mechanical Engineer to drive product design and development for implantable drug delivery systems. The ideal candidate will have extensive experience in medical device design, a rigorous approach to design for manufacturability (DFM), expertise in geometric dimensioning and tolerancing (GD&T), and a solid grounding in Good Manufacturing Practice (GMP). Familiarity with unique challenges and regulatory requirements for implantable devices, and a strong orientation toward application-specific tolerances is desired. Come Join Us! You'll be part of a talented and dedicated team of engineers, scientists, and other professionals at Vivani Medical, an emerging biopharmaceutical company developing a pipeline of miniature, long-term drug implants with its proprietary NanoPortal™ platform technology for obesity/weight management and other chronic diseases.

  • Drive the mechanical design of implantable drug delivery systems, from conceptualization through commercialization, with a focus on meeting demanding implantable device standards.
  • Apply design for manufacturability principles early in the design phase to ensure robust, scalable, and regulatory-compliant implantable products.
  • Ensure all designs are fully compliant with relevant GMP, FDA, and ISO requirements specific to long-term implantable medical devices.
  • Assign all tolerances and material selections with clear justification tied to the end-use environment (e.g., biocompatibility, sterilizability, in-body durability), and anchored in URS and clinical requirements.
  • Collaborate closely with cross-functional stakeholders (R&D, manufacturing, regulatory, clinical) to capture and implement requirements unique to implantation, such as long-term reliability and risk management.
  • Participate actively in design reviews, Design History File (DHF) creation, risk analyses, and verification/validation activities, with emphasis on the unique aspects of implantable device safety and performance.
  • Support the transition from prototyping to scaled manufacturing, addressing material selection, assembly, and cleaning processes suitable for implantables.
  • Document design decisions thoroughly for full regulatory traceability and audit readiness.
  • Bachelor’s degree in Mechanical Engineering (or related biomedical engineering field)
  • A minimum of 6 years of medical device experience.
  • Product design experience for implantable medical devices.
  • Experience with design, development, and manufacturing transfer of implantable drug delivery devices or other active implant systems.
  • A proven track record in meeting clinical and regulatory requirements.
  • Deep understanding of GMP and regulatory demands of implantable devices (including design history files, design controls, risk management).
  • High-level proficiency in design for manufacturability, specifically for products requiring robustness in vivo, sterilization compatibility, and miniaturization.
  • Strong command of GD&T for precision assemblies, with hands-on experience assigning and reviewing tolerances.
  • High proficiency with solid modeling and drawing software (SolidWorks, AutoCAD, or similar), and engineering documentation in a regulated environment.
  • Skillful at translating user needs into clear, actionable URS - including consideration of implant environment, mechanical stresses, and biocompatibility.
  • Effective communicator with a collaborative spirit who's also adept at dealing with shifting priorities (flexible).
  • Medical
  • Dental and Vision
  • Flexible Spending Account (FSA)
  • 401K with Company Safe Harbor Match: 100% /up to 4%
  • Life Insurance
  • Long Term Disability
  • Home Office Stipend
  • Commuter benefits
Track Jobs with Teal

Job Search Resources

•
AI Resume Builder
•
Mechanical Engineer Resume Examples
•
Mechanical Engineer Cover Letter Examples

Tools

Career Hubs

Guides

Company

© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service