Design Assurance Quality Engineer

This opportunity is with an established and funded startup enabling a cure for the millions of patients suffering with atrial fibrillation.

The Design Assurance Engineer (mid-Senior level) will support engineering and new product development activity for the Quality Assurance department in a dynamic and complex environment.

This is a permanent, full-time, on-site role near Woburn, MA.

US Citizen or Green Card required (sorry, this company cannot support a visa transfer)

• Support new product development and product realization through design control phase activity including development, verification, validation, transfer, and associated design reviews for software/data science, hardware/systems, and catheter engineering
• Support sustaining engineering through operational quality activity – material control, inspection/acceptance activity, nonconforming material control, equipment qualification, supplier management, CAPA, and clinical operations including handling and control of protected health information
• Support software design, development, risk analysis, qualification, and version release activity and applicable documentation deliverables, including relevant cybersecurity considerations
• Participate in risk management activity - analysis and documentation applied throughout the product development process
• Inspect and test materials, equipment, processes, and products to ensure quality specifications are met
• Support test method development and qualification activity
• Support the design engineering teams for catheter, hardware, software and systems throughout the design control process
• Design and implement quality system processes to comply with regulatory standards
• Foster a culture of trust, open communication, and continuous improvement, with an unwavering focus on advancing patient outcomes

• Degree in Mechanical, Biomedical Engineering or related applicable engineering field
• Minimum of 5 years experience in product development, quality engineering or a related role in a regulated medical device product development
• Experience in catheter, hardware, software and systems design and development, or with similar medical devices, while working within an early stage Quality Management System
• Applied understanding of 21 CFR 820, ISO 13485:2016, ISO 14971:2019, IEC 60601-1:2020, IEC 62304:2006, GDPR, and HIPAA regulations
• Demonstrated expertise in Process Validation, Product Validation, and Statistical Methods
• Experience in risk management and design controls
• Excellent communication skills, good documentation practices (formal protocols and reports), attention to detail, and project management skills

Pay range and compensation package: $125-165K

We are committed to building a diverse and inclusive workplace and consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, or any other protected characteristic.