Senior Device Engineer

Why Patients Need You

Whether you are involved in the design and development of medical devices and combination products, manufacturing processes or process validation, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative Global Technology & Engineering team, you'll help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

Working with Pfizer’s dynamic engineering team, you will play a critical role in supporting the design and development of medical devices and combination products, including robust manufacturing processes and on-market change control to bring products from R&D to manufacturing. You will leverage your technical capabilities to understand the inherent problems related to transfer of technology from the R&D stage to manufacturing, in cooperation with Quality & Operations. You may oversee testing and measurement throughout the stages of product & process development and and troubleshoot production process problems with processes or equipment already in operation.

As a Senior Engineer, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams. It is your dedication and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

Role Overview
- Technical leader responsible for Medical Device and Combination Product (MDCP) Device Engineering.
- Responsibilities includes New Product Development/Co-Development, on-market product and process change management support and risk management for Medical Devices and Combination Products.
- Scope of role is focused on Global Medical Devices and Combination Products manufactured by Contract Manufacturers and Pfizer Manufacturing Sites (Primarily European sites, but may include support of North American locations).
- Center-function role with cross-functional interfaces, including Pfizer Global Supply (PGS) External Supply Operations, Sterile Injectable & Biotech Operations, Quality and Global Technology & Engineering Device Engineering Lifecycle Management.

How You Will Achieve It
- Support development of strategy to assess and manage risks related to Design and Process robustness for Medical Devices and Combination Products.
- Coach, guide and influence internal and external manufacturing sites in effective management of MDCP’s with respect to industry best practices, e.g. Design & Development, Manufacturing Control Plans, Process Validation and Risk Management.
- Provide technical support for design & process changes, good documentation practices, product risk management as related to manufacturing & supply-chain considerations.
- Develop preliminary design impact assessments for change requests related to MDCP's ; develop execution plan and/or coordinate with operations, engineering and validation to implement or qualify changes.
- Identify opportunities for design or process improvement, develop and execute project plans for implementation.
- Support internal/external site assessment and selection process.
- Support root-cause analysis and troubleshooting for supply-continuity issues related to MDCP components/products.
- Support investigations of customer complaints related to MDCP’s.
- Identify, communicate, and develop mitigation strategies for technical risks with key stakeholders per appropriate escalation thresholding.
- Identify Design History File (DHF) enhancements / updates and collaborate with Engineering Lifecycle Management for execution/implementation.
- Represent device engineering on change / CAPA review board as needed.
- Supports site readiness for new product introduction and launch at internal/external manufacturing.

**Qualifications**:
Must-Have
- Bachelor's Degree in Packaging/Mechanical/Chemical Engineering or related technical discipline.
- 5+ years of demonstrated experience in Medical Device or Combination Products Design Assurance, Quality Engineering, Validation or related area.
- Ability to work independently and as a member of a team and in collaboration with other functional groups.
- Strong technical knowledge of complex Medical Device and/or Combination Products technologies.
- Ability to understand new processes and low to moderately complex methodologies.
- Leverages interpersonal and communications skills to review, discuss, and inform key stakeholders of concepts to drive informed decisions.
- Analyzes moderately complex technical issues and uses technical judgment to impact decisions.
- Agile learner of new processes.
- Knowledge of regulations and ability to work within complex quality system requirements (design controls).
- Strong technical, critica