Job Description Summary

The Senior Quality Engineer will ensure the timely completion of design control (including risk management) deliverables in support of pre-release activities and will execute post-market activities.

Job Description

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 MedTech 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. 

Roles and Responsibilities:

• Collaborate on design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements.

• Engage in design and development and post-market 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 ISO14971 standards to ensure product safety, including defining critical quality attributes, assessing residual risks, and presenting risk/benefit justifications to executive leadership.

• Perform and document Risk Reviews to communicate results of the risk management process to the cross-functional teams.

• Find opportunities for continuous improvement of the Risk Management Process

Required Qualifications:

• Bachelor’s degree in engineering field and 4 years of Quality, Design Controls, Risk Management experience within the medical device industry

• Minimum of 3 years of Post-Market Quality, specifically complaint trending/data analytics. 

• Advanced knowledge of risk management, design controls, regulatory, quality engineering polices, principles and standard methodologies

• Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including ISO 14971 and ISO 13485.  

• 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

Preferred Qualifications:

• Experience with Hazard Analysis or FMEA and verification/validation.

• Strong knowledge of IEC 62304 

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.

Why Join Us?

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 need people who can see the bigger picture, who understand the human story that underpins