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.
• 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.
• Provide Quality Engineering support for anomalies (e.g., software bugs, cybersecurity vulnerabilities, etc.) encountered in production and development projects. Guide triage and remediation efforts.
• 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.
• Provide Quality Engineering support for released products, interfacing with customer support representatives and account executives as necessary.
• Support other areas of the Quality System and perform other tasks as defined by Management.

Requirements:

• B.S./M.S. in relevant engineering field (e.g., biomedical, software, electrical, etc.) or equivalent scientific degree.
• 8+ years of progressive Quality Engineering experience in the medical device industry with hands-on support for hardware and software development.
• 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 verbal and written communication skills and presentation skills.
• Exceptional attention to detail with the proven ability to wear many hats.
• Manage multiple projects while independently prioritizing work, growing the quality culture, and being an advocate for quality and regulatory compliance.
• Must be comfortable working in a high-growth company with rapidly evolving needs, responsibilities, and expectations.
• Creative problem solver.
• Proficient in Microsoft Office, Adobe Acrobat, statistical analysis (e.g., Minitab), and other business software.

• 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.
• Provide Quality Engineering support for anomalies (e.g., software bugs, cybersecurity vulnerabilities, etc.) encountered in production and development projects. Guide triage and remediation efforts.
• 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.
• Provide Quality Engineering support for released products, interfacing with customer support representatives and account executives as necessary.
• Support other areas of the Quality System and perform other tasks as defined by Management