Development Process Engineer

Job Title: Development Process Engineer

Location: St. Paul, MN (100% Onsite)

Duration: 1-Year Contract (with possible extensions)

Rate: $50 - $65/hr

Classification: W2

Work Authorization:

Must be authorized to work in the United States now and in the future without the need for employment-based visa sponsorship. Sponsorship is not available for this position. Candidates requiring H-1B, L-1, TN, O-1, E-3, H-1B1, F-1, OPT, CPT, J-1, or any other form of employment-based visa sponsorship will not be considered.

We are seeking a Development Process Engineer with 5+ years of manufacturing engineering experience to support process development, validation, and continuous improvement initiatives within a regulated manufacturing environment. This role will focus on Design for Manufacturability (DFM), yield improvement, equipment qualification, cost reduction, and new product introduction (NPI) support.

The ideal candidate has strong experience working in cross-functional enterprise environments, particularly within medical device or similarly regulated industries, and is comfortable leading process improvements while maintaining compliance with FDA, QMS, and EMS standards.

• Bachelor’s Degree in Chemical, Industrial, Mechanical Engineering, or related discipline
• 5+ years of manufacturing engineering experience in medical device or related regulated industry
• Experience documenting process improvement initiatives
• Strong analytical, problem-solving, and project management skills
• Experience working in a matrixed, cross-functional enterprise environment
• Proficiency with MS Office (Word, Excel, Outlook, PowerPoint)
• Strong communication skills (written and verbal)
• Must be authorized to work in the U.S.

• Medical device manufacturing experience
• Experience interfacing closely with R&D teams
• Delivery system experience focused on yield improvement, cost reduction, and capacity increase
• Lean Six Sigma Green or Black Belt certification

Process Development & Validation

• Establish manufacturing processes based on product specifications.
• Evaluate process and design alternatives using Design for Manufacturability principles.
• Run Design of Experiments (DOE) to characterize processes and improve yield and efficiency.
• Conduct equipment qualifications and process validations.
• Understand Cost of Goods Sold (COGS) implications in process decisions.

Continuous Improvement & Lean Manufacturing

• Improve product quality, throughput, and labor efficiency using Lean tools and DMAIC methodologies.
• Drive cost reduction initiatives and process optimization efforts.
• Lead root cause investigations and implement corrective actions.

Project & Equipment Management

• Manage projects involving new production equipment, tooling, and process improvements.
• Coordinate design, procurement, build, and debugging of tooling, machinery, and test equipment.
• Support new product introductions (NPI).

Cross-Functional Collaboration

• Work closely with R&D, Quality, Finance, and Operations to define process inputs and outputs.
• Coach and mentor technicians, operators, and trainers.
• Maintain strong collaboration across enterprise and divisional teams.

Compliance & Regulatory

• Ensure compliance with FDA regulations, QMS, EMS, OSHA, and company policies.
• Manage program compliance with Design Control and Process Validation requirements.
• Understand IP considerations related to process development.

• Improved process yield, efficiency, and cost performance
• Successful equipment qualification and validation
• On-time delivery of NPI and process improvement initiatives
• Strong cross-functional alignment in a regulated manufacturing environment