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Senior Principal Quality Engineer

2 months ago

Brockton, Massachusetts, United States Baxter Full time
About Vantive

Vantive is a new company built on the legacy of Baxter, a leading global innovator in kidney care. Our mission is to provide best-in-class care to patients worldwide, and we're committed to revolutionizing kidney care and other vital organ support.

Your Role

The Senior Principal Quality Engineer - Twin Cities, MN role offers an exceptional opportunity to lead groundbreaking efforts in product development and sustainment within Baxter's innovative environment. Located in Plymouth, this position allows you to contribute to the creation and maintenance of medical devices that meet the highest standards of quality and regulatory compliance.

Key Responsibilities
  • Work closely with product engineering to support Product Life Cycle Management (PDLM) activities, including generating Design Plans and reviewing design inputs, outputs, verification, validation, and design transfer strategies, including risk management.
  • Manage activities of self and others in achieving defined quality goals in an efficient, accurate, and timely manner.
  • Provide support to product sustaining engineering specifically through risk and change control management.
  • Provide support to post-market activities such as complaint investigations, complaint trending, NCR / CAPA, and FA processes as necessary.
  • Provide informed recommendations to DHF and risk remediation activities.
  • Act as a domain expert and play a crucial role in compliance audits and FDA/Ministry of Health inquiries.
  • Provide mentorship and training to project personnel, ensuring they understand how to effectively apply design, statistical, and analytical tools.
  • Offer technical support and mentorship for monthly Product Quality Data Reviews.
  • Support audit and compliance activities at the site.
  • Assist in decision-making for process improvement efforts.
  • Mentor others in the areas of Quality Engineering and Quality Management System regulations.
  • Ability to work under deadlines and changing priorities with minimal supervision.
Requirements
  • B.S Degree in engineering.
  • Requires 10+ years of experience in Quality, Manufacturing, Engineering in the Medical Device industry. Cross-industry experience is a plus (e.g., automotive, aerospace, combination products).
  • Medical Device regulatory experience preferred (FDA, EU MDR, etc).
  • Proficiency in Excel required.
What We Offer

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices.

To that end, this position has a base salary range of $120,000 to $165,000 plus an annual incentive bonus and equity target.