Prin R-D Engineer
12230 World Trade Drive San Diego, CA 92128 US
HM's Top Needs:
- Experience with risk management
- Medical device experience
- Product development experience
Years’ Experience Required:
Bachelors Degree in Mechanical Engineering or other relevant science related discipline and 7+ years mechanical design, product development, design verification and validation, and/or risk analysis.
Advanced Degree in Mechanical Engineering or other relevant science related discipline and 5+ years mechanical design, product development, design verification and validation, and/or risk analysis.
Responsibilities may include the following and other duties may be assigned.
The Prin. R&D Engineer will support a QMS transition, involving focused support on remediation of the risk management file, test method validation support, and support of an equipment management system change. This role will serve as the R&D lead to developing a Design FMEA and updating active Hazard Analyses into new formats. The role will involve communication with the Quality organization leading the QMS transition, but will also interface with post-market surveillance, failure analysis, and Ops quality teams. ?
The ideal candidate is a mechanical engineer with experience in product/project development, risk management, design verification, and validation. The candidate is comfortable navigating Quality Management Systems for Medical Device, associated EDMS systems (Agile), and has experience with product/component development using CAD software (SolidWorks). The Prin. R&D Engineer will have the ability to understand complex and compact electromechanical systems and preferably experience with plastic injection molding.
The person filling this role will become part of a dynamic and fast paced Hardware R&D group, creating close working relationships with multiple departments (Quality, Operations, Medical Affairs, Regulatory, et. al.). The candidate possesses a strong command of technical communication, is comfortable processing and explaining complicated data output, and is accountable for results. The key to being successful in this job is the ability to multi-task, work and communicate effectively cross functionally, and drive projects to closure within specified milestones.
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