Baxter is looking to solve the problem of ensuring quality in their software and hardware product development by providing leadership in design control, risk management, and other Quality Engineering activities for new product development projects.
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.
Other
- Establish and nurture strong relationships with cross-functional product development team members to optimize success of development projects.
- Exceptional attention to detail with the proven ability to wear many hats.
- Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
- Creative problem solver.
- Applicants 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.
