Sr. Principal Device Engineer

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

• 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.

• 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 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

• 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 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 methodsfor data analysis.

• Experience with Computer Aided De