Job DescriptionJob Responsibilities: (Primary Duties, Roles, and/or Authorities)Sustaining:
- Own the end-to-end execution of product engineering projects, including Sustaining Change Requests, Product Stewardship requests, and Obsolescence projects. Extract, collect, analyze, and summarize data files and report to stakeholders.
Design:
- Designs, develops and implements products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings. Select appropriate materials, processes and vendors to achieve the design, and challenge these designs against design specifications, clinical use scenarios and international standards. Plans, coordinates and builds test parts for engineering evaluation, pre-clinical studies and clinical studies. Makes and presents engineering decisions. Participates and leads cross-functional teams through design and development stages.
Process Development:
- Develop new or existing processes by understanding key process inputs and outputs, using statistical methods such as DOE as appropriate. Develops process equipment and tooling, including specification development, vendor selection and negotiation.
Documentation:
- Prepare work instructions and standard operating procedures (SOP), write technical documents and reports. Prepare raw material specifications and drawings. Prepares verification and validation protocols and reports.
Test Method Development:
- Develop or modify 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:
- Perform lab bench testing, conduct engineering and competitor evaluations, development unit testing. Plan, develop, coordinate and execute verification and validation activities for existing products and processes.
Training:
- Train technicians in design and process development as well as new/modified test methods. Conduct process development training with operations and quality assurance in conjunction with R&D technicians.
Supervisory/mentoring/coaching:
- Mentor/coach R&D technicians through activities like process development, R&D materials/inventory control etc. May supervise or manage technicians, engineering interns or associate engineers.
Fiscal:
- Participation in our creation and control of 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.
Minimum Requirements- B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
- Minimum of 6 years of industrial experience, preferably in R&D or process development.
- 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.
- Training in Six Sigma or Design for Six Sigma.
Preferred Qualifications- Master's degree in relevant engineering discipline plus 1-3 years medical device or equivalent industry experience
- Experience in R&D or process development in medical device or other regulated FDA/QSR and ISO environment
- Knowledge of cGMP and GLP.
- Experience creating and executing project plans.
- Experience and willingness to lead cross functional teams, across multiple time zones (Domestic and International).
- Experience in project management tools and methodologies
- Basic tooling, design and drafting knowledge.
- Proficient in statistical software with ability to analyze data, interpret results, and write reports
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.
Primary Work LocationUSA AZ - Tempe Headquarters
Additional LocationsUSA NY - Glens Falls
Work ShiftAt BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."
Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.
Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.
Salary Range Information$95,900.00 - $153,400.00 USD Annual
