Development Process Engineer

Job Title: Development Process Engineer

Location: Plymouth, MN

Duration: 12 Months

Job Description:

Key Responsibilities:

• Lead the design, development, implementation, and improvement of manufacturing processes and equipment.
• Specify, acquire, and validate equipment to support production and process improvements.
• Apply structured problem-solving and root cause analysis to resolve process and quality issues.
• Develop and implement corrective and preventive actions (CAPA).
• Design and execute DOE, analyze process data, and present findings to cross-functional teams.
• Drive continuous improvement initiatives to improve product quality, reduce waste, and increase manufacturing efficiency.
• Develop and maintain SOPs, risk assessments, validation protocols, work instructions, and other technical documentation.
• Ensure manufacturing processes comply with internal quality systems and applicable regulatory requirements.
• Collaborate with R&D, Quality, Manufacturing, and Supply Chain teams to support product development and process scale-up.
• Provide technical guidance and training to technicians and junior engineers.
• Evaluate and recommend new materials, tools, technologies, and manufacturing methods.
• Support tooling development, process validation, and implementation of new and existing products.

Required Qualifications:

• Bachelor's degree in Mechanical, Biomedical, Chemical Engineering, or a related field with 2 5+ years of relevant experience, or a Master's degree with 0 2 years of experience.
• Strong analytical, troubleshooting, and problem-solving skills.
• Experience with technical documentation and process development.
• Ability to work independently and collaborate effectively with cross-functional teams.
• Strong communication and presentation skills.
• Working knowledge of manufacturing systems, automation, and process controls.

Preferred Qualifications:

• Experience in the medical device industry, particularly catheter manufacturing or other regulated manufacturing environments.
• Knowledge of GMP, ISO 13485, and FDA regulations.
• Hands-on experience with process validation, DOE, statistical analysis, and continuous improvement methodologies.

Benefits:

Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity:

Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.