Staff Product & Process Design Engineer

Job Title: Staff Product & Process Design Engineer Locations: Franklin Lakes, NJ / Covington, GA (Onsite) Employment Type: W2 only Duration: Long term Job Summary We are seeking a Staff Product & Process Design Engineer to lead manufacturing technology strategy and product industrialization for new and existing medical device products. This role focuses on Design for Manufacturing and Assembly (DFMA), product design optimization, and scalable production transfer into manufacturing sites. The engineer will collaborate closely with R&D and cross-functional engineering teams to support new product development (NPD), feasibility studies, proof of concept (POC), and product design changes. This role is critical in ensuring manufacturability, cost efficiency, quality, and production scalability. Key Responsibilities Define and drive manufacturing technology strategy for new product development and design changes Lead DFMA (Design for Manufacturing and Assembly) and DFSS (Design for Six Sigma) activities Perform CAD-based Assembly Tolerance Requirement (ATR) analysis to ensure design feasibility Partner with R&D and engineering teams on product design, feasibility studies, and POC development Establish assembly KPIVs and KPOVs to ensure quality, cost, and cycle time targets are met Develop and implement process controls to ensure consistent product quality and performance Conduct assembly risk assessments and develop pFMEA and mitigation strategies Support product industrialization and transfer to manufacturing sites (internal/external) Develop DFMA standards, processes, and training frameworks for engineering teams Identify improvement opportunities in existing assembly processes and future design integration Drive scalable, cost-effective, and high-efficiency manufacturing solutions (OEE, CapEx, COGS focus) Provide technical leadership and mentoring to product and process design engineers Review and update CAD models to ensure compliance with design and manufacturing requirements Contribute to intellectual property development related to assembly and design innovations Required Qualifications Bachelor’s degree with 10+ years OR Master’s degree with 8+ years experience in advanced manufacturing engineering, product design, or technical leadership Background in medical devices or highly regulated industries Strong expertise in CAD tools (SolidWorks preferred) Experience in DFMA and Design for Assembly / Manufacturing principles Experience with tolerance analysis (ATR) and engineering design optimization Knowledge of DFSS and process validation concepts Strong understanding of manufacturing process development and industrialization Salary The hourly rate/salary for this position is based on experience. Benefits Benefits will be provided by the hiring client in accordance with their policies. Equal Opportunity Employer We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Background Check Background checks may be conducted in accordance with applicable laws Work Authorization Applicants must be authorized to work in the United States