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