Do you want to use your Quality Engineering skills to make a difference in the world of cardiac monitoring and arrhythmia diagnosis? Do you want to work with a leadership team that has successfully taken previous medical device startups to both clinical and commercial success? Bardy Diagnostics is an exciting growth-stage company with a unique and compelling product looking for the right Quality Engineer to help us achieve our mission.
Join a multi-skilled, dedicated, and talented team developing a state-of-the-art wearable cardiac monitor and associated arrhythmia detection and reporting software. In this full-time, regular-employee role, work in a dedicated team focused on the development of this device, and with a penchant for continuous improvement and engineering excellence.
The right person will be energized by the unique challenges of a medical device startup environment and by solving interesting problems associated with the technology and rapid growth.
Responsibilities
• Support Product Development and Sustaining Engineering projects – provide RAQA project guidance for hardware and software projects, document review & feedback, provide appropriate design and production and process control requirements for product lifecycle phases (planning, design V&V, design transfer).
• Support and provide guidance and feedback on the preparation of documentation, including but not limited to design plans, design inputs, design outputs, test plans, test data, and reports.
• Support/lead Non-Product Software assessments and qualification efforts.
• Oversee qualification of supplier manufacturing processes/products/components.
• Provide production line support, including the review and approval of DHRs, tool qualifications, and sustaining engineering projects.
• Lead the CAPA program – ensure, and support as needed, the effective and efficient processing of open CAPAs in the program, including assigned CAPAs. Host/facilitate monthly CAPA Review Board meetings and communication of CAPA metrics.
• Provide guidance on statistical methods and analyses for Design V&V and Manufacturing process validation, including test method validation (attribute and variable).
• Conduct risk management activities: hazard analysis, risk analysis, identify and evaluate risk control measures, and health hazard evaluations.
• Lead special projects, as needed to support the business.
• Follow documented procedures for all activities related to the Bardy Diagnostics Quality System.
Minimum Qualifications/Education for this role
• Bachelor’s degree in a technical discipline, such as engineering, biology, chemistry.
• Minimum of five (5) years of experience in medical device regulated
quality assurance and quality engineering, and/or regulatory affairs.
• Strong working knowledge of US and international medical device quality system regulation, including 21 CFR 820, MDD/MDR, ISO 13485, and CMDCAS/MDSAP.
• Working knowledge of medical device hardware and software development best practices.
• Strong interpersonal, verbal, and written communication skills.
• Organized self-starter, able to work in a fast-paced environment.
• Ability to work independently and as part of a team, strong collaborative skills.
• Ability to manage competing priorities and “wear many hats” as part of a start-up medical device company.
• Creative problem solver.
• Proficient in Microsoft
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