R&D Engineer III

R&D Engineer III

The role focuses on advanced design validation and testing for legacy product families.

• 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.
• Demonstrate strong cross‑functional collaboration, influence without authority, and project/task management enabling highly effective teams.
• Write and review product development plans, design reviews, technical documents, and reports; prepare and approve verification and validation protocols and reports; develop and implement procedures/policy.
• 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.
• 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.

• Bachelor's Degree in Engineering (Electrical, Mechanical, Biomedical, or related field).
• Minimum of 6 years of related work experience in medical device development within FDA/QSR and ISO regulated environments.

• Proven hands‑on technical capability.
• Ability to lead cross‑functional teams.
• Strong oral and written communication skills, including customer and stakeholder interaction experience.
• Ability to analyze data, interpret results, and write reports; proficiency in statistical software (Minitab).
• Experience in writing protocols, reports, and technical documentation to support verification and validation activities.
• Proficiency with modern CAD (Solid Works).
• Experience in software/firmware development (C/C++, embedded systems, RTOS) and understanding of hardware/software integration.
• Proficiency in 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, PQ) and related documentation.
• 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 senior leadership.
• Willingness to travel up to 10% based on business needs.

Full‑time benefits‑eligible role with a defined three‑year term; a retention bonus will be issued upon conclusion of the term.

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.