Staff Engineer, Process Development

Staff Engineer, Process Development – BD (Tissuemed Ltd)

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the makers of possible 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 Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

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.

• 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 Cap Ex & 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.

• 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.

• 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.

Education

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

• 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…