Catheter Process Development Lead

Actalent; Saint Paul (MN); On-site; USD 100,000 - 117,000; Full time

Benefits offered by this job

Bonus potential

Job summary

Actalent is seeking a Process Development Engineer in Saint Paul, MN to design and optimize robust manufacturing processes for medical devices with emphasis on catheter products. You will lead process development, validation, and cross-functional collaboration to ensure successful commercialization and transfer to production.

The role requires hands-on manufacturing experience, strong statistical analysis skills, and leadership in continuous improvement across sites, with travel between Fridley

Qualifications

• Bachelor's degree in Engineering or related technical field strongly preferred.
• 5+ years in engineering, manufacturing, or process development; exceptions for advanced degrees.
• Proven knowledge of Process Development Engineering and data-driven decisions.

Responsibilities

• Lead design, development, and validation of manufacturing processes for medical devices, esp. catheters.
• Provide technical leadership for commercial product transfers to production.
• Develop and document robust processes for smooth product introductions to manufacturing.
• Execute process design, development, validation, and optimization activities.
• Apply DOE, pFMEA, DFM, and statistics for data-driven decisions.
• Use process validation methods including installation qualification and studies.
• Lead tooling and equipment projects from selection to qualification for production.
• Analyze complex data and support process selection with statistics.
• Communicate project workstreams to engineering, production, and stakeholders.
• Explain technical concepts to senior management, staff, and customers.
• Build cross-functional relationships and drive continuous improvement.
• Mentor engineers and foster a culture of learning and collaboration.
• Collaborate with technicians on the production floor to resolve issues.
• Coordinate regional/multi-site best practices sharing.

Skills

Process Development

Statistical analysis

Design of Experiments

Cross-functional collaboration

Project leadership

Manufacturing processes

Education

Bachelor's degree in Engineering

Tools

pFMEA

DFM

DOE

Minitab

Job description

Actalent is seeking a Process Development Engineer in Saint Paul, MN to design and optimize robust manufacturing processes for medical devices with emphasis on catheter products. You will lead process development, validation, and cross-functional collaboration to ensure successful commercialization and transfer to production.

The role requires hands-on manufacturing experience, strong statistical analysis skills, and leadership in continuous improvement across sites, with travel between Fridley