Senior Process Development Engineer - Catheter

Fridley, MN

Full Time

Experienced

Job Type: Contract or Direct Hire

Job Summary

The Senior Process Development Engineer supports the development, optimization, and validation of manufacturing processes for complex catheter-based delivery systems. The role focuses on post–design-freeze activities such as tooling, fixtures, process characterization, and validation (IQ/OQ/PQ). This engineer serves as a subject-matter expert on cross-functional teams and drives scalable, high-quality production processes.

Key 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.

Qualifications

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.

Physical Requirements

Ability to work at a computer for extended periods.
Ability to lift up to 25 lbs when needed.
Good hand–eye coordination and visual differentiation of small components.
Ability to wear appropriate cleanroom attire when required.

Pay: $100k-$135k DOE Direct Hire

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