Job Description Summary
Primary focus of this position is to assist and lead R&D engineer medical device process development and testing. This would include developing, optimizing, and validating processes for building a medical device; coordinating builds for engineering; developing and performing tests, and collecting, analyzing and presenting data and proposing recommendations to peers and management.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.
Position Summary:
Primary focus of this position is to assist and lead R&D engineer medical device process development and testing. This would include developing, optimizing, and validating processes for building a medical device; coordinating builds for engineering; developing and performing tests, and collecting, analyzing and presenting data and proposing recommendations to peers and management.
Responsibilities:
Coordinates and tracks multiple product builds simultaneously for engineering evaluation, validation, clinical studies, and commercial sales. Assists in developing new processes for medical devices, provides input on tooling/equipment design, and supports procurement of capital equipment while ensuring compliance with GMP requirements.
Initiates and implements comprehensive documentation including work instructions, SOPs, technical reports, and formal test protocols that comply with GMP and Quality requirements. Assists in design and process root cause analysis and supports non-conforming product investigations while ensuring regulatory compliance.
Develops and validates new test methods, conducts tests in collaboration with engineers, collects and analyzes data, performs statistical analysis, and presents findings to peers and management. Sets up test equipment, coordinates protocol execution, and ensures proper equipment maintenance and calibration.
Manages R&D inventory by generating purchase orders, coordinating with vendors, monitoring material and test inventory, handling shipping/receiving (including sterilization), preparing commercial invoices, and maintaining financial logs for R&D expenditures.
Provides process/test method training to manufacturing and QA personnel, performs peer-to-peer coaching for junior technicians, and assists in supporting Manufacturing, Quality, Regulatory & R&D departments to ensure systems compliance with internal and external guidelines.
Required Qualifications:
Minimum of a Highschool Diploma/GED. Experience: 9-12 years of industrial experience in R&D or process development,
Experience working in a laboratory and a controlled environment (cleanroom) with knowledge of GMP and GLP, and an ability to operate lab equipment with practical and technical knowledge of common lab instrumentation and equipment used for test or pilot processes, is required.
Experience in process validation (IQ, OQ and PQ); ability to assist in executing validation.
Advanced proficiency in computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint) including Microsoft Project and Minitab for data analysis.
Develops a working knowledge of, and assists in the completion of, Risk Assessments/FMEA, Design Verification/Validation Test Plans, and Process Validation Master Plans.
Preferred Qualifications:
Associates degree or higher in science, math or engineering preferred.
Ability to analyze and evaluate data and recommend actions; has practical and technical knowledge of root cause and statistical methods and analysis. Develops a working knowledge of statistical analysis and experimental design.
Ability to design (fixture, equipment, and testing). Has a practical and technical knowledge of rapid prototyping techniques and an ability to read and understand CAD drawings (e.g. Solidworks).
Interpret and understand geometric tolerances.
Experience of electronic tools and equipment (soldering, multi-meter, oscilloscope and analyzer, etc.) is preferred.
Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
Work Environment:
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. On occasion the employee may work in a preclinical setting like an animal lab, cadaver lab or attend clinical case observations.
This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.
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.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. 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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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ