Development Engineering Tech I

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.
As R&D Engineer III, your key responsibilities will include:

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. 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; 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.
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.
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.
Ability to analyze data, interpret results, and write reports.
Proficient in statistic software.
Willingness to travel up to 10% based on business needs.
This is a full‑time benefits eligible role, with a defined three‑year term, at the conclusion of which a retention bonus will be issued.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.#We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
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We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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