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. 

As R&D Engineer III, your key responsibilities will include:

• Execute all facets of design validation remediation for legacy product families, including planning, documentation, and testing.

• Conduct gap analyses of existing DV documentation and identify areas requiring remediation to meet current regulatory expectations.

• Collaborate with Regulatory Affairs and Systems Engineering to ensure design validation activities are thorough, risk-retiring, and aligned with global regulatory requirements.

• Update and maintain risk documentation and user needs, to ensure traceability.

• Prepare documentation for regulatory filings, audits, and inspections.

• Demonstrated strong cross-functional collaboration, influence without authority, and project/task management enabling highly effective teams.

• Documentation: write and review product development plans, design reviews, technical documents and reports. Prepares and approves verification and validation protocols and reports. Develops and implements procedures/policy.

• Test Method Development: develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods.

• Training: train technicians and engineers on new design and process development as well as new test methods.

• Support Manufacturing, Quality, Regulatory & R&D to ensure systems are aligned with all internal and external guidelines.

Required Qualifications:

• Bachelor's Degree in Engineering in Electrical, Mechanical, Biomedical or other related engineering field

• Minimum of 6 years' related work experience in medical device development or other regulated FDA/QSR and ISO environment.

Desired Experience and Skills:

• Proven hands-on technical capability.

• Ability to lead cross-functional teams.

• Strong oral and written communication skills, including customer, and/or varying internal/external stakeholder interaction experience.

• Ability to analyze data, interpret results, and write reports. Proficient in statistical software (Minitab).

• Experience in writing protocols, reports, and other technical documentation to support verification and validation activities for product commercialization.

• Proficient with modern CAD (Solidworks).

• Experience in software/firmware development (C/C++, embedded systems, RTOS) and understanding of hardware/software integration.

• Proficiency in the IEC 60601 standards

• Knowledge of cGMP and GLP is a plus

• Training in Six Sigma or Design for Six Sigma.

• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to complete validation.

• Complete understanding of medical device Design Controls process

• Ability to create and implement project plans.

• Basic tooling, design and drafting knowledge.

• Excellent oral and written communication skills presenting data and recommendations to Sr level leadership regularly.

• Ability to analyze data, interpret results, and write reports.

• Proficient in statistic software.

• Willingness to travel up to 10% based on business needs.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.