R&D Engineer III

BD is a global medical technology company seeking an R&D Engineer III to execute design validation remediation, conduct gap analyses, and collaborate with Regulatory Affairs and Systems Engineering. The role involves planning, documentation, and testing, as well as training and supporting cross-functional teams.

Requirements

• 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
• Ability to analyze data, interpret results, and write reports
• Proficient in statistical software (Minitab)
• Experience in writing protocols, reports, and other technical documentation
• 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
• 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

Benefits

• Paid Time Off
• 401k Matching
• Retirement Plan
• Relocation Assistance