R&D Engineer III - Becton Dickinson

Responsibilities

• 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.

• 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.

• 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.

Full‑time, benefits‑eligible role with a defined three‑year term, after which a retention bonus will be issued.

Requires a minimum of four days in‑office presence per week unless otherwise indicated.

Employment is contingent upon proof of full vaccination against COVID‑19. Testing may be available or required in some locations.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, citizenship status, marital or domestic or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

USA AZ - Tempe Headquarters