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.
- Hands-on experience performing Assembly Tolerance Analysis (ATR) and tolerance stack-up assessments.
- Advanced proficiency with CAD and SolidWorks for product and assembly development.
- Experience developing manufacturing processes, assembly systems, fixtures, tooling, and automation solutions.
- Strong knowledge of DFSS, DOE, Statistical Process Control (SPC), Process Capability Analysis, and Process Validation methodologies.
- Experience leading pFMEA, risk assessments, and process optimization initiatives.
- Demonstrated ability to work cross-functionally with R&D, Quality, Operations, Supply Chain, and Manufacturing teams.
- Experience within FDA-regulated, ISO 13485, or similarly regulated manufacturing environments preferred.
Preferred Qualifications:
- Medical device manufacturing experience.
- Automated assembly and high-volume manufacturing experience.
- Lean Manufacturing and Six Sigma certification.
- Technology transfer and global manufacturing support experience.
- Strong technical leadership, mentoring, and project management skills.