Sr. Principal Engineer, Quality
Sr. Principal Engineer, Quality
Posted on :
12-08-2025
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1 Vacancy
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Job Description
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.
- 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.
Employment Type
Full-time
Key Skills
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