Senior Product Development Engineer

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