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Prin R-D Engineer

San Diego, CA 92128

Posted: 12/05/2023 Employment Type: Contract Job Category: Engineering Job Number: 592513 Is job remote?: No Country: United States

Job Description


HM's Top Needs:
  1. Experience with risk management
  2. Medical device experience
  3. Product development experience
    Education Required:

    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.  

    OR 

    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. 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About San Diego, CA

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.