Design Control Engineer III
Pfizer
full-time
Posted on:
Location Type: Office
Location: Andover • Massachusetts, Montana • 🇺🇸 United States
Visit company websiteSalary
💰 $77,100 - $128,500 per year
Job Level
Mid-LevelSenior
About the role
- Lead design control projects for biologics modalities developed as prefilled syringe-based combination products throughout the product and design control lifecycle
- Ensure that combination product development activities are compliant with quality and regulatory standards
- Lead design control and risk management activities for combination product development programs
- Provide input and support for design validation, including human factors engineering assessments
- Support the generation of all regulatory submission data and content for assigned device projects
- Support the assessment of external design companies and suppliers
- Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture
- Support internal and external audits of the DPDD Quality System
Requirements
- BS degree in appropriate Science & Engineering discipline or MS degree in appropriate Science & Engineering discipline
- Minimum of 6 to 8 years (BS) or 4 to 6 years (MS) of relevant experience in the Pharmaceutical Combination Product and/or Device industries
- Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040 and the EU Medical Devices Directive
- Working knowledge of EN 62366 and EU Medical Devices Regulation
- Capable of working independently with minimal supervision
- High level of attention to technical details and accuracy
- Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously
- Able to work collaboratively in cross functional teams
- Proficiency in general computer software such as word processing, spreadsheets, presentations
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
design controlrisk managementdesign validationhuman factors engineeringregulatory submissionquality complianceISO 9001ISO 13485ISO 1497121 CFR 820
Soft skills
attention to detailindependent workprioritizationcollaborationmultitasking