Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
Baxter is seeking a Sr. Principal Software Quality Engineer with 8+ years of progressive experience in medical device Quality Engineering, supporting both hardware and software development. This role provides technical leadership for product quality, design control, risk management, and software quality assurance activities across new and existing product lines.
Responsibilities:
Primary Duties:
- Provide Quality Engineering leadership to product development teams for both hardware and software.
- Lead Design Control and Risk Management activities (plans, hazard analyses, dFMEA/pFMEA, RMF reports).
- Oversee and approve Design History File (DHF) documentation, including design inputs/outputs, V&V, and test planning/protocols.
- Serve as Software Quality SME guiding code reviews, software security analysis, and software BOM.
- Lead implementation of software quality best practices and compliance processes.
- Support transfer to manufacturing, ensuring product quality continuity during launch and field deployment.
- Provide quality oversight and guide resolution of software bugs, anomalies, and cybersecurity vulnerabilities.
Secondary Duties:
- Implement Quality System updates based on new regulations or standards.
- Lead CAPA resolution and closure related to design control processes.
- Support released products and collaborated with customer support as needed.
- Contribute to continuous process improvement and other QA initiatives as directed by management.
Requirements:
- B.S./M.S. in Engineering (Biomedical, Software, Electrical, or related field) or equivalent scientific discipline.
- 8+ years of progressive Quality Engineering experience in the medical device industry
- Technical Expertise:
- Strong working knowledge of
- FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and IEC 62366.
- Hands-on experience with hardware/software design, verification, validation, and electromechanical device testing.
- Expertise in statistical tools and data analysis (e.g., Minitab).
- Proven ability to manage multiple projects and drive quality and compliance culture.
- ASQ CQE and/or Six Sigma (Black/Green Belt) certification.
- Experience with AI/ML, AAMI TIR45, SaMD, and cloud infrastructure quality systems.
Work Environment:
- Hybrid work model (3 days onsite per week or as needed).
- Regular interaction with cross-functional engineering teams.
- Standard office and computer-based work; occasional physical tasks as typical in lab or office settings.