Sr. Device Engineer

Pfizer; New Jersey; Hybrid; USD 83,000 - 138,000; Full time

Benefits offered by this job

401(k) with Pfizer Matching Contrib.

Pfizer Retirement Savings Contribution

Paid vacation

Holiday and personal days

Health benefits

Job summary

Pfizer in the United States is seeking an experienced engineer to oversee device lifecycle management for on-market medical devices and combination products. You will drive change management, risk assessments, design verification plans, and maintain DHF updates while ensuring patient safety and regulatory compliance.

You will lead cross-functional design changes, collaborate with manufacturing, Regulatory, and Quality teams, and mentor colleagues while delivering rigorous documentation and

Qualifications

• Experience with device design controls and risk management in medical devices.
• Familiarity with 21 CFR Part 820, ISO 13485 and ISO 14971.
• Ability to analyze patient/user impact and perform data-driven decisions.

Responsibilities

• Be responsible for device lifecycle management of on-market medical devices and combination products.
• Develop change management technical impact assessments, design and development plans, risk management and design verification plans, test methods and data analysis.
• Lead device and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and to ensure device design integrity is maintained.
• Liaison between GT&E Device Engineering Lifecycle Management (DELCM) and internal production sites, Regulatory, and Quality colleagues.
• Lead design change projects according to internal procedures, track progress, and communicate status to group leadership.
• Establish experimental protocols, conduct experiments, analyze results.
• Lead technical execution of Design History File (DHF) updates.
• Establish and maintain relationships with internal production site colleagues.
• 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, with guidance and supervision.
• Ensure the design controls are documented in accordance with internal procedures.
• Establish and review specifications / requirements for components, products and processes, with guidance and supervision.
• Support CAPA and Complaint investigations, as appropriate.

Skills

Device Design Control

Risk Management

Medical Devices

Combination Products

Statistical data analysis

Independent work & teamwork

21 CFR Part 820 knowledge

ISO 13485 & ISO 14971 knowledge

Education

Bachelor's degree in a STEM field

Master's degree

Associate's degree with 6+ years experience

High school diploma with 8 years experience

Job description

Use Your Power for Purpose

At Pfizer, we believe that every role contributes to our mission of improving patients' lives. Whether you are involved in the design and development of manufacturing processes for products or supporting the upkeep of systems, engineering is crucial to ensuring customers and patients receive the medicines they need. By collaborating with our forward-thinking engineering team, you'll play a pivotal role in accelerating the delivery of medicines to the world.

What You Will Achieve

In this role, you will:

• Be responsible for device lifecycle management of on-market medical devices and combination products.
• Develop change management technical impact assessments, design and development plans, risk management and design verification plans, test methods and data analysis.
• Lead device and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and to ensure device design integrity is maintained.
• Liaison between GT&E Device Engineering Lifecycle Management (DELCM) and internal production sites, Regulatory, and Quality colleagues.
• Lead design change projects according to internal procedures, track progress, and communicate status to group leadership.
• Establish experimental protocols, conduct experiments, analyze results.
• Lead technical execution of Design History File (DHF) updates.
• Establish and maintain relationships with internal production site colleagues.
• 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, with guidance and supervision.
• Ensure the design controls are documented in accordance with internal procedures.
• Establish and review specifications / requirements for components, products and processes, with guidance and supervision.
• Support CAPA and Complaint investigations, as appropriate.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
• Demonstrated knowledge and experience in Device Design Control, Risk Management, Medical Devices, and Combination Products.
• Experience analyzing patient/user impact.
• Understanding and practical knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards.
• Critical thinking, and problem-solving skills.
• An ability to work independently as well as a member of a team in a fast-paced environment.
• Working knowledge of statistical methods for data analysis.

Bonus Points If You Have (Preferred Requirements)

• Relevant pharmaceutical experience.
• Proficiency in continuous improvement and Statistical Process Control methodologies, such as DMAIC and Six Sigma.
• Familiarity with a wide range of package performance testing equipment and methods.
• Understanding of regional pharmaceutical compendia testing requirements.
• Excellent communication and interpersonal skills.
• Strong organizational skills and attention to detail.
• Demonstrated leadership capabilities and mentoring skills.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.
• Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

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%.

Work Location Assignment: Hybrid

The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary.

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. 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.

Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.

EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Pfizer is an E-Verify employer.

This position requires permanent work authorization in the United States.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users.

If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail].

This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

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 Karrieren bei Pfizer sind einzigartig. In unserer Kultur der individuellen Verantwortung glauben wir an unsere Fähigkeit, die Zukunft der Gesundheitsversorgung zu verbessern und an unser Potenzial, viele Millionen Leben zum Besseren zu wandeln. Wir suchen stets nach neuen Talenten für unsere globale Gemeinschaft, um gemeinsam neue innovative Therapien zu entwickeln, die die Welt zu einem gesünderen Ort machen.