LCI - Lawinger Consulting, Inc. · 1 month ago
Principal Process Development Engineer - Catheter
Fridley, MN
Full-time, Contract
Onsite
Lead/Staff
$130K/yr - $185K/yr
10+ years expLCI - Lawinger Consulting, Inc. is seeking a Principal Process Development Engineer specializing in catheter-based delivery systems. This role focuses on leading the development and implementation of innovative manufacturing processes while ensuring high performance and quality during new product introduction.
Information TechnologyRoboticsSoftware
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
Qualification
Required
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
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
Company
LCI - Lawinger Consulting, Inc.
For 25 years, Lawinger Consulting, Inc., has provided innovative IT solutions to help our clients thrive • Our clients range from Fortune 500 companies (General Mills, 3M, Lifetouch, Medtronic, State of Minnesota & others) seeking global team partnerships to small businesses requiring inexpensive, low-maintenance solutions.
51-200 employees
H1B Sponsorship
LCI - Lawinger Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2024 (1)
2022 (1)
Funding
Current Stage
Growth StageCompany data provided by crunchbase