A contract manufacturing medical device client is looking for a direct hire Senior Mechanical Engineer to join their team in Santa, Clara. This person you will lead product development teams to bring complex designs from concept to market and is required to be onsite 5 days a week. We are looking for someone who can play a key role in the development of novel catheter based medical devices so must have a design background specifically in that space!
ESSENTIAL RESPONSIBILITIES
- Lead product development of complex catheter based medical devices through various phases of concept feasibility, detailed design and verification
- 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 main 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
QUALIFICATIONS
- BS in Mechanical / Biomedical Engineering with minimum 5 years of experience within the Medical Device industry
- Must have a minimum of 3 years developing and designing catheters
- Extensive knowledge and experience with product development of catheter based medical devices
- Strong understanding of catheter manufacturing (i.e. braiding, extrusions, material selections, balloons, etc.)
- Hands on experience with catheter prototyping
- Proven experience and proficiency using SolidWorks for mechanical design
Base Salary of $140-165K + bonus, depending on skill set
