Sr. Device Engineer

Use Your Power for Purpose

At Pfizer our mission is to cultivate a bestinclass culture of continuous improvement and project management empowering colleagues and streamlining processes. Whether managing projects or collaborating with others your role in this team is crucial in simplifying and accelerating our work. Join us in this mission to inspire excellence and create a lasting impact on patients worldwide.

What You Will Achieve

In this role you will:

• Responsible for device lifecycle management of onmarket 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.

• Ensure the design controls are documented in accordance with internal procedures.

• 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 NonConforming Reports and the qualification of material / processes / changes to assure reliability requirements are met with guidance and supervision.

• 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 bachelors degree with at least 2 years of experience; OR a masters degree with 0 years of experience; OR an associates degree with 6 years of experience; OR a high school
  diploma (or equivalent) and 8 years of relevant experience.

• Prior experience in Medical Device or Combination Products Design Controls Production Sustaining Engineering or Quality.

• Strong knowledge and experience in Device Design Control Risk Management Medical Devices and Combination Products.

• Experience analyzing patient/user impact.

• Experience in a GMP regulated industry.

• Critical thinking and problemsolving skills.

• An ability to work independently as well as a member of a team in a fastpaced environment.

• Working knowledge of statistical methods for data analysis

Bonus Points If You Have (Preferred Requirements)

• Substantial work experience in consumer operations or project management

• Proficiency in System Application & Products

• Strong leadership and team management skills

• Ability to work effectively in a fastpaced dynamic environment

• Strong analytical and problemsolving skills

• Ability to build and maintain strong relationships with stakeholders

• High level of adaptability and willingness to learn

• Understanding and practical knowledge of 21 CFR Part 820 ISO 13485 and ISO 14971 and related standards.

• Experience with Computer Aided Design (CAD) software.

PHYSICAL/MENTAL REQUIREMENTS

• Officebased role supporting virtual teams via webex and phone.

• Flexibility required when working with global colleagues in various time zones.

NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• Must be able to travel up to 20%.

Work Location Assignment:Hybrid

Last Day to Apply: May 17 2025

The annual base salary for this position ranges from $80300.00 to $133900.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 (). 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.

Continuous Imprv and Proj Mgmt