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.

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
• 6-9 years of industrial experience in R&D or process development
  • Alternative: Masters degree plus 4-6 years experience
  • Alternative: Ph.D. degree with 3-4 years experience
• Demonstrated hands-on technical aptitude
• Experience in process validation (IQ, OQ and PQ)
• Ability to write protocols and reports for verification and validation activities
• 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
• Proficiency in statistical software
• Ability to travel ~ 25%, both domestic and internationally, as needed.

Preferred Qualifications:

• Masters degree in relevant engineering discipline
• Preferably experience in medical device or regulated FDA/QSR and ISO environment
• Knowledge of cGMP (current Good Manufacturing Practices) and GLP (Good Laboratory Practices)
• Biomedical Engineering or Bioengineering degree is preferred
• Training in Six Sigma or Design for Six Sigma

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. 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 Company27s 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 BD27s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.