Staff Engineer, Process Development

BD Medical Device Assembly Process Development Technical Leader

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.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.

The mission of this role is the development of superior products and efficient processes through rigorous execution of DFA enabling high impact innovation and sustainable growth. This role will assume technical leadership of projects and champion technical excellence in product assembly and process development. This candidate will have a passion for developing robust, well thought-out medical device assembly processes that optimize business success through production of high-quality products. This technical leader is a partner with R&D and Operations on new product development with a view to launching advanced manufacturing processes while meeting the product requirements and project timelines.

Responsibilities include:

• Define manufacturing technology strategy for new products (NPD) and product design changes, influence product design through design for assembly (DFA) analysis and enable successful industrialization (internal or external).
• Work with the R&D cross functional team on product design and process development for new products.
• Collaborated with product development engineers on defining manufacturable product specifications.
• Perform DFM/A (Design for Manufacturability/Assembly) assessments.
• Establish assembly requirements KPIVs and KPOVs to ensure effective equipment selection as well as informing process validation strategy.
• Design new assembly processes that are efficient, scalable and within the targeted CapEx & COGs.
• Present complex data in a clear and concise manner to all levels of the organization.
• Author characterization reports as required.
• Handle R&D pilot scale builds to support development activities.
• Present any risks and develop mitigation plans that relate to new product industrialization.
• Assemble the opportunities for existing assembly processes and identify areas for improvement and inclusion into future DFA.
• Provide experience in cross-functional collaboration and leadership skills.
• Support operations during a production challenge. (quality, supplier, etc.)?.
• Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
• Other duties as assigned.
• 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
• 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.
• Support development of all products and process documentation.
• Support in-process test and/or inspection procedure development.
• Planning, ordering and management of component inventory.
• Developing new product cost estimates.
• Support preparation of capital equipment requisitions (CB2).
• Evaluation and recommendation of new materials.

Qualifications include:

Education:

BS degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or equivalent required.

Required Experience:

Min 8 years' experience with BS or 5 years' with MS degree

5+ years of experience in advanced manufacturing engineering, product design, and/or technical leadership level in Medical Device or other highly regulated industries. OR 5+ years of professional experience in mechanical design, with a significant and demonstrable focus on applying DFMA principles.

Demonstrated experience leading/deploying Advanced Manufacturing initiatives.

Experience in process validation, writing protocols and reports to support verification and validation activities for product commercialization; ability to complete validation.

Experience with both manual and semi-automated production lines preferred.

Desired Experience:

Textile/medical textile processing.

Extrusion, knitting, etc.

Knowledge:

Intermediate/Sophisticated knowledge of design and simulation software's such as the following: SolidWorks, AutoCAD.

Basic tooling, design and drafting knowledge.

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.

Understanding of GD&T, component tolerance stack up and assembly tolerance requirements.

Risk analysis / pFMEA.

Understanding of project management and budgeting.

Abilities:

Ability to build and implement project plans.

Ability to analyze data, interpret results, and write reports.

Proficient in statistical software: Minitab

Excellent technical skills including project management, organization, planning, and capital budgets.

Ability to interpret, edit and correct part drawings

Able to act in multicultural environment and worldwide matrix organizations.

Excellent Interpersonal Skills - able to express ideas and collaborate effectively 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.

Relocation Assistance

May Be Available For This Position Subject To Company Policy.

All Candidates Are Welcome To Apply And Will Be Evaluated Equally.

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 Company's 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 BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.

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 health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

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.