Principal Process Development Engineer - Catheter

Fridley, MN

Full Time

Experienced

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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