Job Description Summary

This position is for a hands-on Sr R&D Engineer responsible for supporting the Peripheral Intervention BU focused on maintenance of business projects and improving existing products within our PAD and ESKD portfolio. This position works cross-functionally to lead research and development efforts of complex medical devices.

Job Description

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. 

Responsibilities (including supervisory and/or fiscal):

• Design: Designs, develops and implements new products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings. Makes and presents engineering decisions. Contribute ideas and/or generate intellectual property submissions.

• Demonstrated strong cross-functional collaboration, influence without authority, and project/task management enabling highly effective teams.

• Process Development: develops new processes by understanding key process inputs and outputs, using statistic methods such as DOE as appropriate. Develops new process equipment and tooling, including specification development, vendor selection and negotiation.

• 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.

• Testing: conduct engineering and competitor evaluations, and development unit testing. Plan, develop, implement and manage verification and validation activities for new products and processes.

• Training: train technicians and engineers on new design and process development as well as new test methods.

• Supervisory/mentoring/coaching: Mentor/coach R&D technicians and engineers through New Product Development activities. May supervise or manage technicians, engineers or supervisors.

• Fiscal: Creates, controls, manages a project budget (expense and/or capital expenditure). Create and critique engineering cost analysis.

• Support Manufacturing, Quality, Regulatory & R&D to ensure systems are aligned with all internal and external guidelines.

• Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.

Required Qualifications:

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering field.

• Experience: 6-9 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Master's degree with 4-6 years or Ph.D. with 3-4 years, medical device or equivalent industry experience).

• Demonstrated hands-on technical capability.

• 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.

• 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.

Preferred Qualifications:

• B.S. degree in Computer Information Systems or Computer Science or Engineering or relevant degree.

• Software / Firmware medical systems and their associated devices experience a plus

• Experience in software/firmware development (C/C++, embedded systems,