Job Description Summary

The Sr Engineer, Risk Management role will be responsible for leading and managing risk management activities to ensure the safety, compliance, and quality of our products and processes. This role is crucial in identifying, assessing, and mitigating risks throughout the product lifecycle, from development to post-market surveillance.

Key responsibilities include analyzing and developing solutions to engineering problems related to products or processes, establishing and applying engineering standards and procedures, and providing expert advice on risk management issues across multiple product lines. Owns and develop local procedures in alignment with global policies and technical standards and conduct training for associates across the business unit.

Identify and execute performance improvement opportunities, support successful implementations within business units, and build risk management capabilities using contemporary performance improvement tools including but not limited to Failure Modes and Effects Analysis (FMEA), Risk Matrices, SWOT Analysis, Monte Carlo Simulation and Root Cause Analysis (RCA).

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 Responsibilities:

• Lead the Risk Management Program, ensuring compliance with regulatory requirements and company policies.

• Conduct risk assessments, including Failure Modes and Effects Analysis (FMEA).

• Support quality assurance functions, including deviation resolution, product impact analysis, and corrective and preventive actions (CAPA).

• Develop, review, and maintain risk management documents, standard operating procedures (SOPs), and validation protocols.

• Support internal and external regulatory body audits.

• Participate in new product development projects, supporting work required for each design phase.

• Analyze and track product quality data/metrics to support quality objectives, CAPAs, projects and management reviews.

• Lead multi-functional team, including R&D, manufacturing, medical affairs, and regulatory affairs to ensure effective risk management practices.  Be the SME on risk management processes and train others.

• Foster a collaborative environment by working closely with other quality areas and plant departments to share knowledge and standard methodologies.

• Experience with medical device quality systems, product validation, and statistical analysis.

• Excellent problem-solving, communication, and project management skills.

• Team-oriented mentality with the ability to work effectively in a collaborative environment.

Education and Experience (Required)

• BS in science, Engineering, Quality, or a related field. A MS is preferred.

• Experience: Minimum of 8 years in quality, R&D, and/or manufacturing functions within the medical device industry or similarly regulated industries.

Knowledge and Skills

• Certifications: ASQ Certified Quality Engineer (CQE) or similar certification is preferred.

• Technical Skills: Demonstrated proficiency in risk management tools and methodologies.Applied knowledge to influence product design or manufacturing based on risk management outcomes.

• Regulatory Knowledge: In-depth knowledge of ISO 13485, EU Medical Device Regulations, and FDA QSR Part 820.

• Soft Skills: Strong analytical, problem-solving, and project management skills. Excellent communication and interpersonal skills.

• Collaboration: Proven ability to work effectively in cross-functional teams and foster a collaborative environment.

Work Environment

• In office, on site work environment is required

• Travel to other facilities/locations may be required, up to 10%

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. 

Required Skills

Optional Skills

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Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift