San Francisco Bay Area, CA
Principal R&D Mechanical Engineer (Tech Lead)
Our company is a vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.
As a Principal Mechanical Engineer, you will lead dedicated product development teams to bring complex mechanical designs from concept to market. You will be responsible for the development of long-term implants, delivery systems and external medical devices.
- Lead product development of complex mechanical / electro-mechanical medical devices through various development phases.
- Lead creation of product requirements and design specifications, and determine applicable regulatory standards and ensures appropriate integration into product requirements.
- Generate and maintain computer-aided drawings (CAD) using Solidworks, schematics and component specifications to document mechanical designs.
- Drive hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs, and recommend and implement design modifications.
- Perform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability and manufacturability requirements.
- Serve as the principal technical contact with customers and communicate directly with customers to understand project / product needs, and present technical updates, risks and issues.
- Effectively interface with and manage suppliers to fabricate prototype and final components.
- Develop test plans and protocols, and executes prototype testing and design verification testing.
- Lead and contribute towards creation of risk management documentation, including FMEAs.
- Create engineering-level manufacturing process instructions, bill of materials and related manufacturing documentation.
- Proactively anticipate technical risks and issues, and formulate and implement risk mitigations and corrective/preventive actions.
- Assist program managers in developing and maintaining project plans, and in tracking program health in terms of schedule, budget, and technical risks and issues.
- Collaborate with cross-functional team members to create and maintain Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements.
- Mentor and provide guidance to other engineers and technicians.
- BS in Mechanical / Biomedical Engineering with minimum 10-15 years’ experience within the Medical Device industry.
- Experience with development of permanent implants and delivery systems highly preferred.
- Extensive experience in development of mechanical and electro-mechanical medical devices from concept through design verification and transfer to manufacturing.
- Knowledge of materials and processes used in manufacture of catheters and development of Nitinol components highly preferred.
- Strong understanding of mechanical component manufacturing (i.e. injection molding, machining, sheet metal fabrication, etc).
- Proven experience and proficiency using Solidworks for mechanical design.
- Strong working knowledge and understanding of GD&T.
- Excellent communication skills, both written and oral.
Protective Clothing Required: None
Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.