About the position
We are the makers of possible. 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. We are seeking a highly skilled and experienced Sr Product Engineer to join our dynamic team. The role will work with cross-functional teams within our MMS INF organization to drive consistent best practices for the CAPA process. Deploy CAPA processes and systems that improve compliance, efficiencies, and overall effectiveness. The Sr Product Engineer is responsible for partnering with MMS Infusion counterparts to develop processes and metrics that result in attaining MMS Infusion business improvement objectives and growth strategies. The ideal candidate will have a strong background in technical problem-solving, extensive knowledge of medical device design controls and risk management, and exceptional project management capabilities. The role requires meticulous attention to detail, effective communication skills, and the ability to drive CAPA processes to ensure compliance and continuous improvement in a regulated environment. This role will be responsible for CAPA program management and oversight, including but not limited to initiation, coaching, and training CAPA owners with investigation, root cause analysis, write-up, monitoring for verification and tracking, trending, and reporting of the CAPA program.
Responsibilities
- Lead and manage the CAPA Initiation phase across MMS Infusion, ensuring timely and successful delivery of the problem statement and ownership alignment.
- Prepare and deliver clear, concise presentations to communicate CAPA metrics and trends.
- Owning activities including, but not limited to, the following: CAPA initiation, closure, and investigation support of assigned CAPA owners.
- CAPA Metric Analysis.
- Assisting in the communication with regulatory agencies, notified bodies, and competent authorities.
- Track-wise administration oversight across MMS Infusion.
Requirements
- Bachelor's degree in engineering or related technical field; advanced degree preferred.
- Minimum of 3 years of experience in the medical device industry with a focus on CAPA management, design controls, and risk management.
- Proven experience in technical problem solving with a structured approach to root cause analysis.
- Comprehensive understanding of regulatory requirements and standards applicable to medical devices (e.g., FDA QSR, ISO 13485).
- Excellent project management skills, including the ability to prioritize tasks, manage timelines, and deliver results within budget.
- Strong organizational skills and attention to detail ensure accuracy and completeness in CAPA documentation and records.
- Outstanding communication skills, both verbal and written, with experience in effectively presenting technical information to diverse audiences, including during audits.
Nice-to-haves
- Certification in Quality Management (e.g., ASQ Certified Quality Manager) or related disciplines.
- Experience with CAPA software systems and tools.
- Knowledge of Lean Six Sigma principles and methodologies.
Benefits
- Competitive salary range of $102,000.00 - $168,200.00.
- Opportunities for professional development and growth.
- Performance-based rewards and recognition programs.
