The mission of this role is the development of superior products and efficient processes through meticulous execution of design for manufacture & assembly (DFMA) enabling high impact innovation and sustainable growth. This role will assume technical leadership of projects and champion technical excellence in product assembly. This role will engage with R&D ensuring the manufacturability of new products. This candidate will have a passion for developing robust, well thought-out medical device assembly equipment/processes that optimize for business success through production of high-quality products with best-in-class OEE processes. This technical leader is a partner with R&D and Operations Assembly Equipment Design Team for new product introductions with a view to launching sophisticated manufacturing processes & automation while meeting the needs and timelines for customer focus.
Duties and Position Responsibilities
- 01Define manufacturing technology strategy for new products, support product design by manufacturability analysis of the devices and their packaging and ensure a successful transfer to the production floor.
- 02Lead engineering efforts to build pilot lines of new manufacturing processes to attain process capability and OEE.
- 03Responsible for working with R&D across UCC on the design and development of current and new products.
- 04Perform DFA (Design For Assembly) and DFSS (Design For Six Sigma) analysis and establish assembly requirements and implement process controls to ensure product quality and consistency.
- 05Define manufacturing technology strategy for new products (NPD) and product design changes, influence product design through design for manufacture & assembly (DFMA) analysis and enable successful industrialization (internal or external) and transfer to the factories.
- 06Ensure the assembly process is understood well to minimize risk.
- 07Develop and execute assembly risk mitigation plans.
- 08Ensure execution of DFMA efforts will lead to achieving COGS/GP targets in business case.
- 09Capture the opportunities for existing manufacturing processes and identify areas for improvement.
- 10Capture the opportunities for existing manufacturing processes and identify areas for Design new manufacturing processes that are efficient, within the targeted CapEx & COGS, and scalable.
- 11Suggest alternative design iterations, exploring various form factors, materials, functional solutions to address user needs and manufacturing constraints.
- 12Support process validations to ensure compliance with regulatory requirements.
- 13Collaborate cross-functionally, especially with R&D and manufacturing specialists to ensure the design aligns with product requirements, and product designs are optimized for manufacturability, assembly, and overall performance.
- 14Subject matter expert in DFMA, engineering, and process for assembly.
- 15Review and revise detailed CAD models of product designs, ensuring accuracy/adherence to specifications, standards and manufacturing requirements.
- 16Participate in design verification/testing activities.
- 17Present complex data in a clear and concise manner to all levels of the organization.
- 18Comply with all local, state, federal, and BD safety regulations, policies, and procedures.
- 19Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
- 20Other duties as required by manager.
Support new product team design activities including
- 21Provide technical leadership in the concept development of design control documentation.
- 22Works both independently and/or collectively to develop project plans and execution of prioritizing and scheduling assignments to meet business goals.
- 23Lead technical process reviews.
- 24Work with design team to ensure components/assemblies are designed for manufacturability/excellence (DFM/DFx).
Able to plan, coordinate and lead all technical activities associated with
commercialization and launch of new products including
- 25Conceptualization and development of all manufacturing processes and methods.
- 26Coordination of all development and manufacturing of new tooling and equipment.
- 27Support makes vs buy analysis and identifying new vendors.
- 28Support site selection activities.
- 29Coordination and support of all new vendor equipment, tooling, molds, etc.
- 30Support development of all products and process documentation.
- 31Support in-process test and/or inspection procedure development.
- 32Planning, ordering and management of component inventory.
- 33Performing process characterization of all new operations and processes.
- 34Developing, implementing, analyzing, and writing reports for validation protocols.
- 35Developing new product cost estimates.
- 36Support preparation of capital equipment requisitions (CB2).
- 37Evaluation and recommendation of new materials.
Education and/ or Experience
- 38B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or equivalent required.
- 39Min four (4) years’ experience or two (2) years’ with MS degree.
- 40Experience in mechanical design, with focus on applying DFMA principles.
- 41Industrial experience in process development is preferred.
- 42Ideally experienced in medical device production.
- 43Experience in process validation, writing protocols and reports to support verification and validation activities for product commercialization; ability to complete validation.
Knowledge, Skills and Abilities
- 44Basic/Intermediate knowledge of design and simulation software’s such as the following: SolidWorks, AutoCAD, 3DCS, ProModel, FlexSim.
- 45Basic/Intermediate knowledge applying tolerance stack-up methodologies and GD&T to evaluate dimensional variation, support DFMA initiatives, and ensure robust product performance at scale.
- 46Able to act in multicultural environments and worldwide matrix organizations.
- 47Ability to build and implement project plans.
- 48Basic tooling, design and drafting knowledge.
- 49Ability to analyze data, interpret results, and write reports.
- 50Experience with both manual and semi-automated production lines preferred.
- 51Excellent Interpersonal Skills - able to express ideas and collaborate optimally with multidisciplinary teams.
- 52Ability to work with minimal guidance, conceptualize ideas, motivate, and focus individuals and teams and drive projects through completion on time and on budget.
- 53Understanding and ability to implement DOEs, process characterizations and validations using standard statistical techniques.
- 54Understanding of GMPs and medical device regulations as they apply to manufacturing.
- 55Ability to interpret, edit and correct part drawings
- 57Understanding of project management and budgeting
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WHY JOIN US?
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit 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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