Manufacturing Process Engineer

Intellectt Inc; Minnesota; On-site; USD 70,000 - 90,000; Full time

Job summary

An established industry player is seeking passionate Manufacturing Engineers to enhance the production of surgical products in the medical device sector. In this pivotal role, you'll collaborate with various teams to streamline manufacturing processes, ensuring compliance and quality. Your expertise will drive continuous improvement initiatives, focusing on innovative technologies and best practices. Join a dynamic environment where your contributions will significantly impact product development and operational excellence. If you're ready to make a difference in life sciences and medical manufacturing, this opportunity is perfect for you.

Qualifications

• 6+ years of engineering experience, with 3 years in the medical device industry.
• Strong knowledge of manufacturing process validation (IQ, OQ, PQ).
• Experience with metal processing and mechanical assembly.

Responsibilities

• Collaborate with cross-functional teams to ensure smooth manufacturing processes.
• Design and purchase tooling and equipment for manufacturing.
• Lead efforts to reduce rework and optimize manufacturing efficiency.

Skills

Manufacturing Engineering

GMPs

ISO 13485

Lean Manufacturing

Six Sigma

Communication

Cross-functional Collaboration

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Biomedical Engineering

Tools

Oracle

Job description

2 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from Intellectt Inc

Passionate Recruiter – connecting and hiring talents to support the Life Science/Pharmaceutical industry/ medical devices/manufacturing roles

We are seeking a highly skilled 5 Manufacturing Engineers to join our team, supporting the design, implementation, and validation of manufacturing processes for surgical products in the medical device industry. This is a critical role that involves working within cross-functional teams to improve product quality, reduce waste, and drive continuous improvement across manufacturing processes.

Key Responsibilities:

• Collaborate with Quality Assurance, Supplier Quality, Regulatory, Manufacturing, and Planning teams to ensure the smooth operation of manufacturing processes for surgical products.
• Design, develop, specify, and purchase tooling, fixtures, and equipment used in the manufacturing process.
• Manage the implementation and validation of new or modified manufacturing processes and equipment, focusing on IQ/OQ/PQ validation.
• Support material selection and validation for polymers, metals, adhesives, and other materials used in medical devices.
• Create and maintain BOMs, Routers, and DMRs, ensuring that all manufacturing processes meet regulatory requirements and are well-documented.
• Lead efforts to reduce rework, scrap, and labor variance while optimizing manufacturing efficiency.
• Investigate and resolve manufacturing-related problems through the Material Review Board process, ensuring high product quality and compliance.
• Identify and implement innovative manufacturing technologies and best practices to improve processes and product quality.
• Serve as a technical expert, providing manufacturing engineering knowledge to resolve issues and improve existing products and processes.
• Represent the Manufacturing Engineering group on key projects and drive continuous improvement across all manufacturing operations.

Desired Qualifications:

• Bachelor’s degree in Mechanical, Manufacturing, Materials, or Biomedical Engineering (or equivalent).
• Minimum of 6 years of engineering experience, with at least 3 years in the medical device industry.
• Strong knowledge of GMPs, ISO 13485, and manufacturing process validation (IQ, OQ, PQ).
• Experience with metal processing (machining, polishing, welding), plastics processing, and mechanical assembly.
• Knowledge of Six Sigma, Lean Manufacturing, and Continuous Improvement methods.
• Expertise in machine/tool design and equipment startup (preferred).
• Experience in a cleanroom environment is a plus.
• Ability to analyze and troubleshoot manufacturing processes, improving equipment uptime, yield, and quality.
• Experience with financial analysis related to project cost assessments and capital purchases.
• Strong communication, teamwork, and cross-functional collaboration skills.
• Familiarity with Agile and Oracle systems is a plus.
• Ability to travel up to 10% domestically.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Manufacturing

• Industries

  Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Chemical Manufacturing

Referrals increase your chances of interviewing at Intellectt Inc by 2x

Sign in to set job alerts for “Manufacturing Process Engineer” roles.

Principal Manufacturing Process & Packaging Engineer (Remote Eligible, Minneapolis Preferred)

Sr. Manufacturing Process and Packaging Engineer - Minneapolis, MN

Minnesota, United States $192,640.00-$288,960.00 3 weeks ago

Eden Prairie, MN $70,000.00-$90,000.00 3 weeks ago

Industrial Engineer II, Operational Excellence

Minnesota, United States $91,100.00-$136,700.00 1 year ago

Manufacturing Process Integration Sr. Engineer

Manufacturing Process Development Engineer

St Cloud, MN $56,000.00-$84,000.00 2 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.