Job Description Summary

This 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.

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. 

Essential / Key Job 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. Participates and leads cross-functional teams in the design of a medical device. Contribute ideas and/or generate intellectual property submissions.

• 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, execute 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

Other Responsibilities may include, however are not limited to:

• Support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant 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 discipline. Biomedical Engineering or Bioengineering degree preferred.

• 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 (Masters degree plus with 4-6 years or Ph.D. degree with 3-4 years, medical device or equivalent industry experience).

• 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 execute validation.

• Ability to create and execute project plans.

• Ability to lead cross functional teams.

• Basic tooling, design and drafting knowledge.

• Excellent oral and written communication skills.

• Ability to analyze data, interpret results, and write reports. Proficient in statistic software.

• Training in Six Sigma or Design for Six Sigma.

Preferred Qualifications:

• Masters degree in relevant engineering discipline.

• Knowledge of cGMP and GLP is a plus.

• Background in Chemistry

• Experience in combination devices and devices requiring Premarket Approval (PMA)

Education and/or Experience:

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline. Biomedical Engineering or Bioengineering degree preferred.

• 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 (Masters degree plus with 4-6 years or Ph.D. degree with 3-4 years, medical device or equivalent industry experience).

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status. 

Required Skills

Optional Skills

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Primary Work Location

USA AZ - Tempe Headquarters

Additional Locations

Work Shift

NA (United States of America)