Sr. Device Engineer
At a glance
AI generatedTL;DR
Join Pfizer's engineering team as a Device Lifecycle Manager, where you will oversee the lifecycle management of on-market medical devices and combination products. Your responsibilities include developing technical impact assessments, design verification plans, and leading device changes while ensuring compliance with regulatory standards. You will collaborate closely with internal teams to manage documentation updates, conduct experiments, and support manufacturing processes, all while maintaining robust risk management practices. Essential skills include a deep understanding of Device Design Control, Risk Management, and relevant medical device regulations such as 21 CFR Part 820 and ISO 13485. Bonus points for experience with continuous improvement methodologies like Six Sigma and proficiency in AI tools to enhance productivity. This role requires strong critical thinking, problem-solving abilities, and the capacity to work independently while contributing to a team-based environment.
Skills
What you'll do
- Develop and execute change management technical impact assessments for medical devices.
- Lead design verification plans, test methods, and data analysis for device lifecycle management.
- Ensure compliance with regulatory standards by updating documentation and risk files.
- Coordinate between engineering teams, production sites, and quality assurance departments.
- Manage Design History File (DHF) updates to maintain device design integrity.
- Support Manufacturing and Quality Assurance in resolving Non-Conforming Reports.
- Apply statistical methods for data analysis in technical problem-solving.
What we're looking for
- Bachelor's degree or equivalent experience required
- Proven knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products
- Understanding and practical application of 21 CFR Part 820, ISO 13485, and ISO 14971 standards
- Strong critical thinking and problem-solving skills
- Ability to work independently and collaboratively in a fast-paced environment
Employer
About Pfizer
Pfizer Inc. is one of the world''s largest biopharmaceutical companies, researching, developing, manufacturing, and marketing medicines and vaccines across multiple therapeutic areas including oncology, cardiology, and infectious diseases. Industry: Biopharmaceuticals
Pfizer currently has 22 open roles on FindRole.
Listed pay typically runs $106,000–$176,600 across 22 roles with salary data.
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