Sr. Mechanical Engineer
Orange County Metro Area, CA
- Sr. Mechanical engineer who will design and develop a consumable medical device used on the vitreoretinal surgery. As a part of the R&D team, one will perform one or more of the following tasks:
- Be technical lead for new consumable development and ensure that design activities are coordinated for SOP and GMP.
- Responsible for leading, participating in or supporting the product development activities such as prototyping/testing, pilot builds, verification & validation testing, risk assessment and production tooling validation.
- Responsible for project planning and provide technical leadership in project execution
- Adequate skillset with 3-D CAD (Solid Works or Pro-E)
- Equip with a high degree of engineering problem solving skills.
- Knowledge pneumatic design concept
- Able to design complex assembly tool/fixture to support high volume production.
- Knowledge in a high volume manufacturing process (laser welding, press-fit, crimping)
- Excellent teamwork skills with ability to lead.
- Knowledge in plastic injection molding and over-molding.
- Experience with rapid prototype design and build for proof of concept.
- Experience with selection of bio-compatible material.
- Familiar with Medical Device Directive, FDA and other similar regulatory directive.
- Minimum of 10 yrs of engineering with 5 yrs experience in medical device design
- BS in mechanical or bio-mechanical