Bachelor's Degree (10+ years) or Master's Degree (8+ years) in relevant field
Extensive experience in New Product Development (NPD) and commercialization
Strong expertise in Design for Manufacturing and Assembly (DFMA)
Experience with Assembly Tolerance Analysis (ATR) and tolerance stack-up assessments
Proficient in CAD and SolidWorks
Knowledge of Design for Six Sigma (DFSS), DOE, and Statistical Process Control (SPC)
Experience leading pFMEA and process optimization initiatives
Ability to collaborate with cross-functional teams in regulated environments
Responsibilities
Lead process development for new product introductions and manufacturing transfers
Collaborate during design phases to ensure manufacturability
Perform comprehensive DFMA assessments to optimize product processes
Conduct CAD-based assembly analyses to validate product performance
Develop strategies, methodologies, and tools for scalable production
Define Key Process Input and Output Variables for process capability
Design and analyze process characterization studies and validations
Lead pFMEA activities and implement risk mitigation plans
Improve manufacturing processes using Lean and Six Sigma methodologies
Support new manufacturing equipment selection and validation activities
Establish process controls and monitoring strategies
Modify CAD models to ensure compliance with manufacturing standards
Benefits
Collaborative work environment with cross-functional teams
Opportunities for professional development and growth
Engagement with innovative projects in medical device manufacturing
Supportive culture that values continuous improvement
Involvement in meaningful work that impacts patient care
Full Job Description
Job Description: We are seeking a highly experienced Staff Process Development Engineer to lead manufacturing process development activities supporting new product development (NPD), product design changes, and technology transfer within a regulated medical device manufacturing environment. This role will partner closely with R&D, Product Development, Manufacturing Engineering, Quality, and Operations teams to ensure products are designed for manufacturability, assembly, scalability, and operational excellence. Responsibilities:
Lead process development and industrialization activities for new product introductions (NPI), product enhancements, and manufacturing transfers.
Collaborate with R&D and Product Development teams during concept, feasibility, design verification, and design transfer phases to ensure manufacturable product designs.
Perform comprehensive DFMA (Design for Manufacturing & Assembly) assessments to optimize product architecture, assembly methods, cost, quality, and throughput.
Conduct CAD-based Assembly Tolerance Requirement (ATR) analyses and tolerance stack-up evaluations to validate assembly robustness and product performance requirements.
Develop manufacturing process strategies, assembly methodologies, tooling concepts, fixtures, and automation solutions to support scalable production.
Define and establish Key Process Input Variables (KPIVs) and Key Process Output Variables (KPOVs) to ensure process capability, product quality, and manufacturing consistency.
Design, execute, and analyze process characterization studies, DOE (Design of Experiments), capability assessments, and process validation activities.
Lead Process Failure Mode and Effects Analysis (pFMEA) activities and implement effective risk mitigation plans throughout product lifecycle development.
Develop manufacturing standards, best practices, and structured DFMA review processes to support stage-gate product development activities.
Evaluate and improve existing manufacturing and assembly processes through Lean Manufacturing, Six Sigma, and continuous improvement methodologies.
Support equipment selection, process qualification, process validation, and vertical start-up activities for new manufacturing lines.
Establish process controls, monitoring strategies, and statistical methods to maintain long-term manufacturing performance.
Review and modify detailed CAD models and engineering drawings to ensure compliance with manufacturing, assembly, tolerance, and quality requirements.
Required Qualifications:
Bachelor's Degree with 10+ years of experience, or Master's Degree with 8+ years of experience in Process Development, Manufacturing Engineering, Product Development, or Advanced Manufacturing within Medical Device or other highly regulated industries.
Extensive experience supporting New Product Development (NPD) and product commercialization activities.
Strong expertise in Design for Manufacturing and Assembly (DFMA) methodologies.
