Johnson & Johnson - Boston, MA

posted 4 months ago

Full-time - Mid Level
Remote - Boston, MA
Chemical Manufacturing

About the position

The Senior Design Quality Engineer for Digital Orthopedics at Johnson & Johnson MedTech plays a crucial role in supporting product quality and reliability for medical devices and digital health solutions. This position involves ensuring compliance with regulations and standards while collaborating with multi-functional teams throughout the development lifecycle. The engineer will act as a domain specialist for mechanical and electronic hardware, focusing on quality assurance and risk management.

Responsibilities

  • Review all project/program work including plans, requirements, specifications, and test protocols.
  • Provide direction and leadership for the quality of digital health technologies.
  • Guide in establishing product and software requirements, specifications, and detailed design documentation.
  • Collaborate with project teams to ensure compliance with Johnson & Johnson MedTech procedures and global ISO standards.
  • Provide Quality representation during problem resolution and participate in technical design reviews.
  • Apply knowledge of risk management to ensure a risk-based approach for processes.
  • Identify and implement changes to maintain the effectiveness of the quality management system.
  • Lead investigations for complaints, non-conformances, CAPA, and product issues.
  • Support internal and external audits by regulatory agencies.

Requirements

  • A Bachelor's degree in Engineering (Electrical, Systems, Biomedical, Mechanical) or related scientific field required; advanced degree preferred.
  • A minimum of three years of relevant experience focusing on design control, risk management, and verification & validation.
  • A minimum of three years of Quality experience within the medical device, aerospace, defense, or similarly regulated industry.
  • Experience with the application of Data Science and Advanced Statistical Techniques.
  • Strong verbal and written communication skills, with the ability to present issues and plans effectively.
  • Excellent organizational, problem-solving, and analytical skills.

Nice-to-haves

  • Solid understanding of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304.
  • Passion for the development of new technologies and the ability to apply design controls to emerging technologies.

Benefits

  • Flexible work schedule with 3-4 days in the office and 1-2 days working from home.
  • Diversity, equity, and inclusion initiatives.
  • Opportunities for professional development and career growth.
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