Job Description Summary

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. 

Job Summary

The Engineering Manager – Post Market Risk Management is responsible for overseeing and ensuring compliance with risk management requirements throughout the post-market phase of our medical devices and solutions. This role will lead cross-functional teams during post-market risk management reviews to ensure that all necessary risk management activities are executed in accordance with the quality system. This includes, but is not limited to, risks associated with medical devices such as data integrity, systems security, electricity, moving parts, and usability. The role will lead and coach cross-functional teams on risk management processes that support our commitment to innovation and patient safety.

Responsibilities:
•    Manage and lead a team of engineers, providing coaching, mentoring, and professional development opportunities focusing on risk management file updates based on post-market data in accordance with ISO 14971.
•    Develop, maintain, and execute risk management plans that support ongoing sustaining activities in accordance with our risk management framework.
•    Participate in CAPA activities including ownership of CAPA tasks and support field corrective action (FCA) activities.
•    Make decisions and recommendations on required actions associated with product issues (e.g. product hold order, health hazard assessment, and field corrective action).
•    Lead cross-functional discussions with engineering, design, commercial, and product teams to ensure that all hazards associated with products are identified, risks are estimated, evaluated, controlled, and documented.
•    Monitor that risk controls are implemented, verified, and validated for products in the post-market phase and verify the effectiveness of risk control measures throughout the product life cycle.
•    Lead periodic reviews of the risk management process and quality system deliverables to ensure ongoing effectiveness and document decisions and actions taken, aligned with our quality systems and ensuring compliance with regulatory standards and practices.
•    Lead remediation efforts for updating risk management documents and the implementation of the FMEA process.
•    Evaluate estimated risk and acceptability for each risk based on analysis outcomes, utilizing our risk acceptance criteria. If risks are not acceptable, lead efforts to identify and document risk control methods.
•    Support the Benefit-Risk Analysis process and lead the evaluation of overall residual risk, ensuring alignment with our strategic objectives.
•    Perform and document Risk Reviews to communicate results of the risk management process to cross-functional teams.
•    Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members.
•    Facilitate and provide ongoing training on standards/processes as needed to other associates or functions.
•    Foster a collaborative and inclusive team environment, ensuring effective communication and teamwork.

Required Qualifications:
Knowledge, Skills & Abilities:
•    Familiarity with risk management activities that support compliance with various international regulatory bodies, including ISO 14971 and ISO 13485. IEC 60601 and IEC 62304 experience is a plus.
•    Experience in the medical device and/or regulated industry (required).
•    Experience with post market surveillance and risk management activities.
•    Ability to analyze data from proprietary sources to calculate risk probabilities and levels effectively.
•    Strong communication skills to relay department and area issues, ensuring clarity and cooperation across global functional teams.
•    Technical experience with automated dispensing cabinets (preferred).
•    Proven experience in managing and leading teams of engineers, with strong coaching and mentoring skills.

Minimum Educational Level:
•    Bachelor of Science degree in engineering (Mechanical, Electrical, Materials, Biomedical, or related discipline), with a master’s degree preferred.
•    Quality certifications relevant to the industry, such as ASQ Certified Quality Engineering, Certified Auditor, and Six Sigma credentials preferred.

Minimum Experience:
•    8+ years in a regulated industry, particularly within the medical device, bio-pharmaceutical, or biotechnology sectors, with a strong preference for experience at similar organizations.
•    5+ years leading and applying risk management concepts specifically within the context of medical devices ensuring high standards of patient and customer safety.
•    3+ years of experience in a people management role, leading and developing engineering teams.

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 everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. 

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At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

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