Pfizer Sr. Associate, Device Engineer in Kalamazoo, Michigan
Responsible for global Medical Device and Combination Product lifecycle management including scoping product and process change management and risk management.
Responsible to maintain compliance between the on-market product and the Design History File (DHF).
PGS Site facing role to establish activity priority and communicate deliverables and timing.
Provide input and support for device changes, document updates, process changes, risk management
Liaison between GT&E Device Engineering Lifecycle Management (DELCM) and internal production sites, quality, regulatory, medical, clinical, Co-Development, and Tech Transfer / Launch Teams
Plan design change project, track progress, and communicate status to group management
Report and escalate to leadership as needed/agreed
Communicate technical risks to key stakeholders at production sites and group management
Support technical execution of Design History File (DHF) enhancements / updates
Contributor to Annual Product Record Review (APRR)
Represent group and product on change review board (CRB)
Responsibilities will be Product Platform or regionally defined
Accountable for the change management projects related to the device, design, or manufacturing process
Establish and maintain relationships with production sites and key stakeholders
Participate in cross-functional teams in the preparation of risk management documentation, including product impact assessments, risk analysis, hazard analysis, Post Market Surveillance Reports, etc.
Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of new material/ processes to assure reliability requirements are met;
Establishment and review of specifications/requirements for components, products and processes;
Supports CAPA investigations, as appropriate
Advise and consult with device engineers for tactical execution of change management
Bachelor's degree in Engineering, Science or other technical degree
Minimum 3-5 years' experience in Medical Device or Combination Products Design Controls, Production, Sustaining Engineering role or related field
Understanding of Device Design Control and Risk Management requirements
Knowledge of Design for Reliability and Manufacturing (DRM) and robust device design practices
Experience analyzing complex issues for patient/user impact
Experience with FDA investigators and other global regulatory agencies in the front room or providing back room support
Thorough understanding and in-depth knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 and related standards
Strong technical project manager, critical thinking, and problem solving skills
Understanding of production and production systems in a GMP regulated environment
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 30%
Other Job Details
Eligible for Employee Referral Bonus
Telecommuting will be considered for the right candidate
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