Specialist Engineer, Software Quality

This is where your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride. 

Your role at Baxter

As a Software Quality Specialist Engineer, you will lead Quality Engineering activities for software and hardware product development teams, developing and maintaining Risk Management Files and Design History Files. You will provide quality oversight and approval of product development plans and design inputs and outputs, collaborating with teams on software quality and code reviews. Your primary focus will be ensuring quality and compliance in product development and transfer to production.

What you will be doing

• 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.
• Establish and nurture strong relationships with cross-functional product development team members to optimize success of 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.  
• Secondary/Backup Duties and Responsibilities:
• Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
• Own the resolution and timely closure of CAPAs as they relate to the design control process.
• Support other areas of the Quality System and perform other tasks as defined by Management

What you will bring

• 8+ years of progressive Software Engineering experience in the medical device industry
• B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.
• 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.
• 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.
• 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.
• Experience supporting development of classic and artificial intelligence (AI) software algorithms and deep understanding of cloud infrastructure is preferred.

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 employees