Lead DFMA strategy for new products and product design changes to ensure successful commercialization and transfer to manufacturing.
Partner with R&D during product development to influence design decisions that improve manufacturability, assembly, quality, and cost.
Define and develop scalable manufacturing processes, equipment concepts, and assembly methods for new product introductions.
Lead engineering efforts to build pilot lines and establish capable, efficient manufacturing processes that achieve performance, quality, and OEE targets.
Support internal and external manufacturing transfer activities, including industrialization planning and factory readiness.
Manufacturing Process Development
Develop manufacturing processes that meet product requirements, cost targets, and capacity needs.
Perform DFA, DFMA, DFSS, tolerance stack-up, and risk analyses to optimize designs and reduce manufacturing risk.
Identify process improvement opportunities for existing manufacturing operations and implement solutions that improve efficiency, quality, and throughput.
Develop and implement risk mitigation plans for assembly processes and ensure process robustness.
Technical Leadership
Serve as a subject matter expert in DFMA, assembly engineering, and advanced manufacturing processes .
Provide technical leadership for cross-functional project teams and lead technical process reviews.
Guide design teams on best practices for manufacturability, assembly, and process capability.
Present technical data, recommendations, and project updates clearly to stakeholders across multiple levels of the organization.
Validation, Compliance & Documentation
Support verification and validation activities for product commercialization, including protocol development, execution, data analysis, and reporting.
Assist in development of product and process documentation, including design control documentation, process specifications, and inspection/test procedures.
Ensure all activities comply with applicable quality systems, GMP requirements, and regulatory standards.
Follow all safety policies, procedures, and site-specific requirements.
Commercialization Support
Support all technical activities related to new product launch, including: Manufacturing process conceptualization and development
Tooling and equipment development
Vendor identification and support
Make-versus-buy analysis
Site selection support
Capital equipment planning
New product cost estimates
Material evaluations
Inventory and component planning for development builds
Requirements
Education
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a related technical field with 10+ years of relevant experience , or
Master's degree or MBA in Engineering or related field with 8+ years of relevant experience
Required Experience
5+ years of experience in advanced manufacturing engineering, product design, or technical leadership , preferably in medical device or other highly regulated industries
Proven experience applying DFMA principles to product and process development
Experience leading advanced manufacturing or industrialization initiatives from concept through commercialization
Experience in process validation, including writing protocols and reports for verification and validation activities
Strong experience with risk analysis/FMEA, design control, CAD modeling, DFSS, and tolerance stack-up analysis
Experience with digitalization and automation in manufacturing environments
Preferred Experience
Medical device industry experience
Automation and semi-automated manufacturing line experience
Experience with b
Benefits
Health insurance
Additional Information
We are the people who give possibilities purpose
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.
Job Description
We are seeking a highly skilled Product Development Engineer to drive the development of robust manufacturing processes and assembly solutions for new product introductions. This role partners closely with R&D, Operations, and cross-functional engineering teams to ensure products are designed for manufacturability, assembly, quality, scalability, and business success.
The ideal candidate brings deep expertise in Design for Manufacturing and Assembly (DFMA) , process development, and technical leadership within a medical device or other highly regulated manufacturing environment . This person will play a key role in launching innovative products by developing efficient, high-quality manufacturing processes and automation strategies that support operational excellence, product quality, and sustainable growth.