Operational Technology Project Engineer coordinating project deployment plans and timelines for enterprise - level technology operations. Managing teams and documentation in manufacturing environments with continuous operations.
About the role
- Sr. R&D Engineer at BD driving research and development of complex medical devices through design, testing, and collaboration. Engage in innovative processes and mentor teams in new product development.
Responsibilities
- The Sr. R&D Engineer position works cross-functionally to lead research and development efforts of complex medical devices.
- The position designs, develops and implements new products, focusing on project planning, innovative medical device design, prototype development, testing characterization, analysis and reporting.
- Design and develop new products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings.
- Develop new processes by understanding key process inputs and outputs, using statistical methods such as DOE as appropriate.
- Write and review product development plans, technical documents and reports. Prepare and approve verification and validation protocols and reports.
- Develop new engineering test methods and conduct engineering evaluations for new products and processes.
Requirements
- B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
- 6-9 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
- Demonstrated hands-on technical aptitude.
- Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization.
- Ability to create and execute project plans.
- Ability to lead cross functional teams.
- Basic tooling, design and drafting knowledge.
- Ability to analyze data, interpret results, and write reports.
- Proficient in statistic software.
- Training in Six Sigma or Design for Six Sigma.
Benefits
- Health insurance
- 401(k) matching
- Flexible working hours
- Paid time off
- Professional development opportunities
- On-site collaboration emphasis
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