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About Baxter
Baxter is a leading medical technology company that has been pioneering significant medical innovations for over 85 years. Our mission is to save and sustain lives, and we are committed to improving outcomes for millions of patients worldwide.
Job Summary
We are seeking a highly skilled Principal Engineer - Product Quality/Design Assurance to join our R&D project teams in the sustainment of sophisticated medical device projects. As an embedded partner member, you will be responsible for ensuring the team complies with all portions of Design Control and related Quality System elements.
Key Responsibilities
- Prepare, manage, and/or update all Design Assurance required sustaining engineering deliverables.
- Support the remainder of the team in developing a quality product that meets regulatory requirements.
- Ensure product development activities related to verification and validation are fully compliant to the quality system procedures.
- Assist in identification and mitigation of product or process-related risks.
- Support the CAPA and FA process by performing investigations, root cause analyses, and verification of effectiveness checks for design-related issues impacting the field.
- Support internal and external regulatory and customer audits.
- Support adherence to process in Concession Reviews, Engineering Change Reviews, and CAPA Review Meetings.
Requirements
- B.S. in Engineering, preferably Mechanical, Electrical, Electronics, or Computer Engineering.
- 5+ years' experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense) in a design/development/quality role desired.
- Product Design experience may be considered in lieu of Quality Assurance experience.
- Knowledge of Quality System Regulations, Medical Device Directive, and ISO Quality System Standards.
- Knowledge of 21 CFR 820.30, ISO13485, IEC62304 desirable.
- Knowledge of EN ISO 14971:2012; safety by design; Risk Management structure desirable.
- Ability to perform and influence in cross-functional team environments and utilize effective interpersonal skills.
