Principal Device Engineer

Use Your Power for Purpose

Technical Leader responsible for sustaining on-market Medical Device and Combination Products (MDCP) through product / process change and risk management activities. Production site and R&D facing role. Primary responsibilities include facilitating product launch, leading post-market changes and identifying opportunities for continuous improvement.

What You Will Achieve

In this role, you will:

• Lead design changes, process changes and risk management updates. Track progress and communicate status to management
• Guide, motivate and/or oversee the activities of individuals and teams with focus on project/program issues.
• Liaison between GTEL Device Engineering and internal production sites, Regulatory, and Quality colleagues
• Plan and execute technical strategy, protocols, tests and reports for line extensions and market expansion activities with production sites and Regulatory Affairs
• Establish and review specifications / requirements for components, products and processes
• Identify Design History File (DHF) enhancements / updates for specific device presentation / platform•
• Assess trends in post-market surveillance and production controls to identify and execute continuous improvement activities for device presentation / platform and processes
• Support investigations of delivery system customer complaints to determine root cause and implement appropriate corrective and preventive actions
• Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material / processes / changes to assure reliability requirements are met
• Identify, communicate, and develop mitigation strategies for technical risks with key stakeholders per appropriate escalation thresholding
• Contributor to Annual Product Record Review
• Represent device engineering on change / CAPA review board, as needed

Basic Qualifications

• Applicant must have a bachelor's degree with at least 4 years of
  experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a 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 and ISO 14971 and related standards
• Ability to advance new processes and moderately complex methodologies
• Strong technical, critical thinking, and problem-solving skills
• An ability to work independently, guide others and serve as an effective member of a team in a fast-paced environment
• Excellent communication skills (written and verbal) and attention to details
    
  

PHYSICAL/MENTAL REQUIREMENTS

Office-based role supporting virtual teams via webex and phone. Flexibility required when working with global colleagues in various time zones.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Must be able to travel up to 20%

OTHER JOB DETAILS

Last Date to Apply for Job: October 28, 2026.

Referral Bonus Eligibility: YES

Eligible for Relocation Package: NO

Work Location Assignment: Hybrid

 

 

The annual base salary for this position ranges from $99,200.00 to $165,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

 

 

 

 

 

 

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

 

 

Relocation assistance may be available based on business needs and/or eligibility.

 

 

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

 

 

 

 

 

 

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

 

 

Engineering