Baxter is seeking to solve the problem of ensuring high-quality, compliant, and safe medical device development through robust quality engineering practices, in alignment with regulatory standards and the company's mission to save and sustain lives.
Requirements
- 8+ years of progressive Software Engineering experience in the medical device industry
- Experience with the application and implementation of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601 series, IEC 62304, and IEC 62366.
- Experience in the design, development, verification, validation, and test activities for medical device hardware and software, including electromechanical medical devices and both embedded and non-embedded software.
- Experience in the deployment of quality engineering tools for design and process improvement; extensive knowledge of statistical tools and data analysis techniques.
- Proficient in statistical analysis (e.g., Minitab), and other business software.
- Certified ASQ CQE, and/or Six Sigma Black Belt/Green Belt preferred.
- Experience with artificial intelligence, working within an AAMI TIR45 framework, and SaMD is preferred.
Responsibilities
- Provide Quality Engineering leadership for software and hardware product development teams. Responsible for leading design control, risk management, and other Quality Engineering activities for new product development projects.
- Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEAs, pFMEAs, and risk management report.
- Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation. Responsible for quality oversight and approval of product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.
- Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
- Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, and the software BOM; lead implementation of best practices for software quality processes.
- Participate in design reviews to ensure the effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
- Support the successful transfer and hyper-care phase of design and design modifications into production / field deployment.
Other
- B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.
- Must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
- Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
- Exceptional attention to detail with the proven ability to wear many hats.
- Creative problem solver.
