Development Process Engineer

Intellectt Inc; Minnesota; On-site; USD 60,000 - 90,000; Full time

Job summary

A leading company in medical device manufacturing is seeking a Process Development Engineer with a strong background in process validation and experience in regulated industries. The role involves both hands-on and documentation work, collaborating with various teams to support new product development. Candidates should have a Bachelor's degree in Engineering or equivalent experience, and familiarity with CAD tools like SolidWorks is preferred.

Qualifications

• At least 2 years of hands-on experience in process development or manufacturing.
• Experience in medical device or regulated industry preferred.

Responsibilities

• Split between hands-on work and documentation.
• Support new product development and validate/tweak processes.

Skills

Process validation

Statistical analysis

CAD tools

Dimensional testing

Regulated quality systems

Education

Bachelor’s degree in Engineering

Tools

SolidWorks

Job description

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A Process Development Engineer with at least 2 years of hands-on experience in process development or manufacturing, ideally in the medical device industry or other regulated industries (e.g., pharma, aerospace, food). The candidate should be capable of working in both documentation and hands-on process environments.

Technical Skills:

• Process validation and equipment qualification (IQ/OQ/PQ, TMV, MSA, etc.)
• Statistical analysis and sampling
• CAD tools (e.g., SolidWorks)
• Dimensional and force testing (e.g., tensile testing, smartscope)
• Familiarity with regulated quality systems and documentation

Day-to-day activities:

• Split between hands-on work (machine setup, process trials, sample creation) and documentation (reporting, analysis, inspection procedures)
• Work with manufacturing, R\&D, quality engineers, and production operators
• Support new product development and validate/tweak processes
• Document qualification and validation of tooling and procedures

Education:

• Preferred: Bachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, or Electrical)
• Considered: 5+ years of relevant experience in lieu of degree

Experience:

• Minimum 2 years post-graduation (internships alone not sufficient)
• Experience in medical device or regulated industry preferred
• Candidates from pharma, aerospace, or food with relevant skills considered

Top Skills:

• Process validation (IQ/OQ/PQ)
• Regulated industry experience
• Strong documentation and data analysis skills

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Engineering and Design

• Industries

  Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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