Sr. Quality Engineer, Risk Management

Overview

The Sr. Staff Engineer is responsible for leading and managing all quality activities related to design and development (including risk management) and transfer of medical devices to manufacturing. They will lead multi-functional teams during the design and development and post-market phase to ensure that all necessary design control and post-market activities are driven in accordance with the quality system.

We are the makers of possible. BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

• Collaborate on software design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements.
• Ensure cybersecurity are integrated into product design, reviewing software artifacts for compliance and traceability.
• Engage in design and development activities for both medical and non-medical
• Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Design Quality Engineer members that share in varying pieces of the risk management lifecycle
• Oversee risk management using ISO
  14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.
• Find opportunities for continuous improvement of the Design Control (including Risk Management) Process

• Bachelor’s degree in engineering field and 10 years of Quality, Design Controls, Risk Management, or Software experience within the medical device industry
• Working knowledge of IEC 62304 and AAMI TIR
  57
• Advanced knowledge of risk management, design controls, regulatory, quality engineering polices, principles and standard methodologies
• Experience with software Failure Modes Effect Analysis (sFMEA), Security Risk Assessments and defect management, software verification/validation.
• Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including ISO 14971, ISO 62304, TIR 57, IEC 62366, 21 CFR 820.30, HE 75, Human Factors.
• The position requires strong oral and written communication and interpersonal skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we…