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$140,000-175,000/year
Vivani Medical, Inc
Alameda, CA, USA
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ShareWe 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. Key Responsibilities 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. Requirements 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). The role requires 3 days in the office. Legally authorized to work in the US Salary range: $140-$175K Benefits 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
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Wellford, SC, USA