R&D Product Engineer
  • Tempe, Arizona, US
  • +914043515100
10 Days ago
Job Description
3 Must haves:
1. Knowledge of medical device development and manufacturing
2. Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation
3. Ability to create and execute project plans and ability to lead cross functional teams.

Position Summary:
Primary focus of this position is to lead EU-MDR submission of products, including product gap assessments, planning and remediation of gaps within project timelines. Successful candidates will assist in developing, optimizing, and validating components/elements of a medical device, write technical documents, validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting design and process qualification and validation; support test method development and validation, support other activities from R&D, Quality, Operations, and Regulatory Affairs.

Required Qualifications:
• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering Bachelor’s Degree preferred.
• Experience: 4-7 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus 1-3 years medical device or equivalent industry experience).
• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.
• Basic tooling, design and drafting knowledge.
 
Industry
  • NA

Required Skills
  • Not Available

Experience
  • NA

Salary
  • NA

Working Hours / Week
    NA