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.

This is a full‑time benefits eligible role, with a defined three‑year term, at the conclusion of which a retention bonus will be issued.

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.#CLOLI