Manufacturing Process Engineer - Medical Devices

Spectraforce Technologies, Inc.; Saint Paul (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

Spectrum, Spectraforce Technologies, Inc. seeks a Development Process Engineer in St. Paul, MN to lead design, development, and implementation of new manufacturing processes and equipment.

You will specify, acquire, and validate equipment to support production and process improvements onsite in Minnesota. Responsibilities include applying structured problem solving, developing CAPAs, and conducting DOE with data analysis for cross-functional teams.

Qualifications

• Bachelor's degree in engineering with 2-5+ years of relevant experience or Master's with 0-2 years (or equivalent).
• 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 catheter manufacturing or similar regulated environments.
• Familiarity with GMP, ISO 13485, and FDA regulations.
• Hands-on experience with process validation, DOE, and statistical analysis.

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.

Skills

Analytical skills

Problem-solving

Technical writing

Communication skills

Documentation

Team collaboration

Presentation skills

Manufacturing systems knowledge

Process control

GMP & regulatory awareness

DOE & statistics

Education

Bachelor's degree in Mechanical Engineering / Biomedical / Chemical or related field

Master's degree with 0-2 years experience OR 2-5+ years experience in related field

Job description

Spectrum, Spectraforce Technologies, Inc. seeks a Development Process Engineer in St. Paul, MN to lead design, development, and implementation of new manufacturing processes and equipment.

You will specify, acquire, and validate equipment to support production and process improvements onsite in Minnesota. Responsibilities include applying structured problem solving, developing CAPAs, and conducting DOE with data analysis for cross-functional teams.