ISC Engineering, Process Design, Engineer III

Becton Dickinson; Covington (GA); On-site; USD 110,000 - 180,000; Full time

Job summary

BD in Covington, GA seeks a technical leader in DFMA for medical device assembly, partnering with R&D and Operations to translate designs into manufacturable, scalable processes.

You will define manufacturing technology strategy, lead pilot lines, validate processes, and ensure regulatory compliance while driving cost of goods targets.

Qualifications

• B.S. in Mechanical/Biomedical Engineering or equivalent.
• Min four years of experience; two years with MS.
• Experience applying DFMA principles.
• Medical device manufacturing experience preferred.

Responsibilities

• Define manufacturing technology strategy for new products and transfer to production.
• Lead pilot lines to reach process capability and OEE.
• Collaborate with R&D on design for manufacturability and validation.
• Develop DFMA analyses and implement process controls for quality and cost targets.

Skills

DFMA

SolidWorks

AutoCAD

3DCS

ProModel

FlexSim

GD&T

FMEA

Project management

Budgeting

Education

B.S. in Mechanical Engineering

MS degree preferred

Tools

SolidWorks

AutoCAD

3DCS

ProModel

FlexSim

Job description

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

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

• Define 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.
• Lead engineering efforts to build pilot lines of new manufacturing processes to attain process capability and OEE.
• Responsible for working with R&D across UCC on the design and development of current and new products.
• Perform 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.
• Define 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.
• Ensure the assembly process is understood well to minimize risk.
• Develop and execute assembly risk mitigation plans.
• Ensure execution of DFMA efforts will lead to achieving COGS/GP targets in business case.
• Capture the opportunities for existing manufacturing processes and identify areas for improvement.
• Capture the opportunities for existing manufacturing processes and identify areas for Design new manufacturing processes that are efficient, within the targeted CapEx & COGS, and scalable.
• Suggest alternative design iterations, exploring various form factors, materials, functional solutions to address user needs and manufacturing constraints.
• Support process validations to ensure compliance with regulatory requirements.
• Collaborate 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.
• Subject matter expert in DFMA, engineering, and process for assembly.
• Review and revise detailed CAD models of product designs, ensuring accuracy/adherence to specifications, standards and manufacturing requirements.
• Participate in design verification/testing activities.
• Present complex data in a clear and concise manner to all levels of the organization.
• Comply with all local, state, federal, and BD safety regulations, policies, and procedures.
• Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Other duties as required by manager.

Support new product team design activities including

Provide technical leadership in the concept development of design control documentation. Works both independently and/or collectively to develop project plans and execution of prioritizing and scheduling assignments to meet business goals. Lead technical process reviews. Work 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: Conceptualization and development of all manufacturing processes and methods. Coordination of all development and manufacturing of new tooling and equipment. Support makes vs buy analysis and identifying new vendors. Support site selection activities. Coordination and support of all new vendor equipment, tooling, molds, etc. Support development of all products and process documentation. Support in-process test and/or inspection procedure development. Planning, ordering and management of component inventory. Performing process characterization of all new operations and processes. Developing, implementing, analyzing, and writing reports for validation protocols. Developing new product cost estimates. Support preparation of capital equipment requisitions (CB2). Evaluation and recommendation of new materials.

Education and/ or Experience

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or equivalent required.
• Min four (4) years’ experience or two (2) years’ with MS degree.
• Experience in mechanical design, with focus on applying DFMA principles.
• Industrial experience in process development is preferred.
• Ideally experienced in medical device production.
• Experience in process validation, writing protocols and reports to support verification and validation activities for product commercialization; ability to complete validation.

Knowledge, Skills and Abilities

• Basic/Intermediate knowledge of design and simulation software’s such as the following: SolidWorks, AutoCAD, 3DCS, ProModel, FlexSim.
• Basic/Intermediate knowledge applying tolerance stack-up methodologies and GD&T to evaluate dimensional variation, support DFMA initiatives, and ensure robust product performance at scale.
• Able to act in multicultural environments and worldwide matrix organizations.
• Ability to build and implement project plans.
• Basic tooling, design and drafting knowledge.
• Ability to analyze data, interpret results, and write reports.
• Experience with both manual and semi-automated production lines preferred.
• Excellent Interpersonal Skills - able to express ideas and collaborate optimally with multidisciplinary teams.
• Ability to work with minimal guidance, conceptualize ideas, motivate, and focus individuals and teams and drive projects through completion on time and on budget.
• Understanding and ability to implement DOEs, process characterizations and validations using standard statistical techniques.
• Understanding of GMPs and medical device regulations as they apply to manufacturing.
• Ability to interpret, edit and correct part drawings.
• Risk analysis / FMEA.
• Understanding of project management and budgeting.

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 https://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.

Required Skills Optional Skills

Primary Work Location USA GA - Covington BMD

Additional Locations

Work Shift

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.