Principal Device Engineer

Pfizer

. Sustain on-market Medical Device and Combination Products through product/process change and risk management activities .

Posted 10/14/2026full-timeUnited StatesLead💰 $99,200 - $165,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Medical Device and Combination Products, focusing on product/process change, risk management, and compliance with regulatory standards. Proven ability to lead cross-functional teams, facilitate product launches, and implement continuous improvement strategies.

Highest-signal resume keywords

Medical Device Design ControlsGMP Regulated Industry ExperienceKnowledge of 21 CFR Part 820ISO 13485 and ISO 14971 StandardsTechnical Risk Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Product Launch FacilitationRisk ManagementDesign Change ManagementPost-Market Surveillance AnalysisRoot-Cause AnalysisSpecification ReviewContinuous ImprovementTechnical Strategy ExecutionPatient/User Impact AnalysisCorrective/Preventive Actions

Soft Skills

LeadershipCommunication SkillsCritical ThinkingProblem-SolvingTeam Collaboration

Industry Keywords

Medical DeviceCombination ProductsGMPRegulatory ComplianceQuality AssuranceDesign History FileCAPAAnnual Product Record ReviewProduction Control TrendsMarket Expansion Activities

About the role

Key responsibilities & impact

Sustain on-market Medical Device and Combination Products through product/process change and risk management activities
Facilitate product launches, lead post-market changes, and identify continuous improvement opportunities
Lead design changes, process changes, and risk management updates; track progress and communicate status to management
Guide, motivate, and/or oversee individuals and teams on project and program issues
Liaise between GTEL Device Engineering, internal production sites, Regulatory, and Quality colleagues
Plan and execute technical strategies, protocols, tests, and reports for line extensions and market expansion activities
Establish and review specifications and requirements for components, products, and processes
Identify Design History File enhancements and updates for device presentations/platforms
Assess post-market surveillance and production-control trends and execute continuous improvement activities
Support delivery-system customer complaint investigations, root-cause analysis, and corrective/preventive actions
Support Manufacturing and Quality Assurance with non-conforming report dispositions and qualification of materials, processes, and changes
Identify, communicate, and develop mitigation strategies for technical risks
Contribute to Annual Product Record Review
Represent device engineering on change/CAPA review boards as needed

Requirements

What you’ll need

Bachelor's degree with at least 4 years of experience; OR master's degree with at least 2 years of experience; OR PhD with 0+ years of experience; OR associate's degree with 8 years of experience; OR high school diploma (or equivalent) and 10 years of relevant experience
Experience in Medical Device or Combination Products Design Controls or related area
Experience analyzing patient/user impact
Experience in a GMP regulated industry
Strong knowledge of 21 CFR Part 820, ISO 13485, ISO 14971 and related standards
Ability to advance new processes and moderately complex methodologies
Strong technical, critical thinking, and problem-solving skills
Ability to work independently, guide others and serve as an effective team member in a fast-paced environment
Excellent written and verbal communication skills and attention to detail
Ability to travel up to 20%
Candidates must be authorized to be employed in the U.S. by any employer
Permanent work authorization in the United States required
U.S. work visa sponsorship is not available now or in the future

Benefits

Comp & perks

401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Medical, prescription drug, dental and vision coverage
Global Performance Plan with a bonus target of 12.5% of base salary
Eligibility to participate in Pfizer’s share based long term incentive program
Relocation assistance may be available based on business needs and/or eligibility