Development Process Engineer

Position Title: Development Process Engineer 

Work Location: St. Paul, MN, USA, 55117

Assignment Duration: 7+ months

Work Schedule: 8:00 AM – 5:00 PM

Work Arrangement: Onsite

Position Summary:

Lead the design, development, and implementation of new manufacturing processes and equipment.

Specify, acquire, and validate new equipment to support production and process improvements.

Key Responsibilities:

• Lead the design, development, and implementation of new manufacturing processes and equipment.

• Specify, acquire, and validate new equipment to support production and process improvements.

• Apply structured problem-solving methodologies to identify root causes of process issues.

• Develop and implement corrective and preventive actions (CAPAs).

• Design and execute experiments (DOE), analyze data, and present findings to cross-functional teams.

• Drive continuous improvement initiatives to enhance product quality, reduce waste, and increase efficiency.

• Create and maintain technical documentation including SOPs, risk assessments, validation protocols, and safety instructions.

• Ensure all processes comply with internal quality systems and external regulatory requirements.

• Work closely with R&D, Quality, Manufacturing, and Supply Chain teams to support product development and scale-up.

• Provide technical training and mentorship to technicians and junior engineers.

• Evaluate and recommend new materials, tools, and technologies to improve manufacturing capabilities.

• Support tooling development and process validation for new and existing products.

Qualification & Experience

• Bachelor’s degree in engineering (Mechanical, Biomedical, Chemical, or related field) with 2–5+ years of relevant experience OR master’s degree with 0–2 years of experience or an equivalent combination of education and experience.

• Strong analytical and problem-solving skills.

• Proficiency in technical writing and documentation.

• Ability to work independently and collaboratively in cross-functional teams.

• Excellent communication and presentation skills.

• Working knowledge of manufacturing systems, automation, and process control.

• Experience in the medical device industry, particularly with catheter manufacturing or similar regulated environments.

• Familiarity with GMP, ISO 13485, and FDA regulations.

• Hands-on experience with process validation, DOE, and statistical analysis.

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $28.45/hr – $30.00/hr.