Sr. Associate, Device Engineer

ROLE SUMMARY

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.

ROLE RESPONSIBILITIES

• 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

BASIC QUALIFICATIONS

• 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

PHYSICAL/MENTAL REQUIREMENTS

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

#LI-PFE

Sunshine Act

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Engineering