Senior Process Development Engineer - Catheter jobs in United States
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LCI - Lawinger Consulting, Inc. · 1 month ago

Senior Process Development Engineer - Catheter

LCI - Lawinger Consulting, Inc. is seeking a Senior Process Development Engineer to support the development, optimization, and validation of manufacturing processes for complex catheter-based delivery systems. The role involves leading process optimization activities and serving as a subject-matter expert on cross-functional teams to ensure high-quality production processes.

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H1B Sponsor Likelynote

Responsibilities

Develop and validate manufacturing processes for catheter-based delivery systems (e.g., reinforced shafts, balloons, steerable components)
Lead process optimization activities, including DOE studies and data analysis
Create tooling, fixtures, and equipment strategies to improve process efficiency and operator usability
Support smooth transfer of designs into stable, validated production processes
Prepare process development plans, documentation, and validation protocols (IQ/OQ/PQ)
Drive improvements in production controls, safety, training, and quality systems
Support cross-functional activities including operations, quality, program management, and documentation updates (ECOs)
Participate in manufacturing readiness and gate reviews

Qualification

Process developmentManufacturing validationStatistical analysisSolidWorksDesign for manufacturability (DFM)Project managementCollaborationDocumentation

Required

Bachelor's degree in engineering or related field
5+ years of experience in process or product development
Hands-on experience with catheters, balloons, shafts, or similar component manufacturing
Strong understanding of DFM, design controls, statistical analysis, and validation methods
Proficiency in SolidWorks or similar tools and general MS Office programs
Ability to manage multiple projects and collaborate across teams

Company

LCI - Lawinger Consulting, Inc.

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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.

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
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)

Funding

Current Stage
Growth Stage
Company data provided by crunchbase