Sr. Principal Device Engineer

Use Your Power for Purpose

At Pfizer we believe that every role contributes to our mission of improving patients 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 forwardthinking engineering team youll play a pivotal role in accelerating the delivery of medicines to the world.

What You Will Achieve

• 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.

How Will You Achieve It

• Lead highly complex design changes process changes and risk management updates. Track progress and communicate status to management.

• Project management capability for managing complex projects involving stakeholders from multiple areas of the business

• Guide motivate and/or oversee the activities of individuals and teams with focus on project/program issues.

• Lead the develop implementation and maintenance of processes and/or procedures cross functional in scope

• Liaison between GT&E Device Engineering Lifecycle Management (DELCM) and external manufacturing sites Regulatory and Quality colleagues for highly complex technical projects and process improvements

• Develop and execute strategies for lightspeed and/or accelerated development timelines

• Contribute expert level knowledge of device standards regulations processes and/or technology to ensure project success

• Plan and execute technical strategy protocols tests and reports for complex 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 postmarket 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 NonConforming Reports and the qualification of material / processes / changes to assure reliability requirements are met

• Manages the identification communication and development of mitigation strategies for complex 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

• Interface and manage vendors on design control related topics and activities

• Knowledge of design for manufacturing

Here Is What You Need (Minimum Requirements)

• Applicant must have BA/BS with 6 years of experience or MBA/MS with 5 years of experience or PhD 1 year of experience

• Effective written and verbal communication skills

• Strong interpersonal skills and the ability to work collaboratively in a team environment across various business functions

• Experience in project management and leading complex projects

• Ability to develop and manage plans to achieve objectives

• 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.

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

• 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 methodsfor data analysis.

• Experience with Computer Aided Design (CAD) software.

Bonus Points If You Have (Preferred Requirements)

• Experience in problemsolving negotiations presentation and supervision of a multilayered organization

• Understanding of DAMIC (six sigma) tools and practices with a focus on continuous improvement

• Broad knowledge of technology transfer processes and manufacturing for Active Pharmaceutical Ingredients

• Good technical understanding of pharmaceutical processes and the impact of technical change

• Demonstrated experience and competence in organizing planning and problemsolving related to qualifying new API suppliers

• Strong leadership and team management skills

• Excellent analytical and strategic thinking abilities

• Ability to influence and drive alignment across stakeholders

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

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

Travel up to 10%.

Work Location Assignment:Hybrid

Last Date To Apply: May 14 2025

The annual base salary for this position ranges from $120800.00 to $201400.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 17.5% 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 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.

Engineering

#LIPFE