Sr. Associate, Device Engineer
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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