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Job Type: Contract or Direct Hire

Job Summary

The Principal Process Development / NPI Engineer leads the development and implementation of cost-effective product designs and manufacturing processes for complex catheter-based delivery systems. This role focuses on process innovation, scale-up, and ensuring high performance and quality during new product introduction.

Key Responsibilities

+ Lead development of processes for components, sub-assemblies, and finished devices.

+ Mentor and guide engineers and technicians; provide technical leadership within project teams.

+ Serve as the link between development and operations to ensure smooth manufacturing transfer.

+ Drive creation of robust, repeatable processes that consistently meet design and quality requirements.

+ Develop project plans, schedules, and resource requirements.

+ Support improvements in production controls, SOPs, safety, quality, and training.

+ Plan and maintain layouts for equipment and manufacturing areas.

+ Lead manufacturing launches for new or updated products, including training and performance evaluation.

+ Design or source tooling, fixtures, and equipment, including cost/ROI analysis.

+ Analyze process capability, production efficiency, and quality metrics.

+ Create and revise engineering change documentation (ECOs).

+ Support cross-functional groups such as quality, operations, regulatory, and finance.

+ Identify and implement process improvements and new technologies, including automation.

+ Specify, purchase, install, and validate new equipment or processes.

+ Prepare capital expenditure justifications.

+ Support product transfer from development to manufacturing.

+ Contribute to Lean initiatives and continuous improvement efforts.

Qualifications

+ Bachelor’s degree in engineering or related field.

+ 10+ years of experience in process or product development involving catheter-based or similar complex assemblies.

+ Strong background in process validation, DOE, process characterization, and test method development.

+ Proven ability to develop manufacturing processes from concept through production scale-up.

+ Experience with DFM, design controls, quality systems, and structured development processes.

+ Ability to manage multiple projects and drive cross-functional results.

+ Strong interpersonal, communication, and influence skills.

+ Proficiency with SolidWorks, Mastercam, and standard office software.

+ Ability to handle sensitive or confidential information.

Physical Requirements

+ Ability to sit and work at a computer for extended periods.

+ Ability to lift up to 25 lbs as needed.

+ Good hand–eye coordination and ability to distinguish small components.

+ Ability to wear cleanroom-appropriate attire when required.

Pay: 130k-185k DOE Direct Hire

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