Senior Manufacturing Engineer: Process Scale & Optimization

Coloplast; Plymouth (MN); On-site; USD 95,715 - 143,573; Full time

Benefits offered by this job

Health and Wellness

401(k) with company match

Paid time off

Flexible work hours

Tuition reimbursement

Recognition programs

Sustainability initiatives

Job summary

Coloplast in Minnesota (Plymouth) is seeking a Senior Manufacturing Engineer to support implantable Interventional Urology manufacturing by developing and implementing procedures that maximize labor, material and equipment utilization while meeting regulatory requirements.

You will lead process improvements, perform validations, manage capital projects, and ensure GMP compliance. The role requires 5+ years in manufacturing, strong analytical skills, and proven project management capabilities.

Qualifications

• 5+ years of related manufacturing work experience.
• Strong analytical and problem-solving skills with continuous improvement focus.
• History of successful project management.

Responsibilities

• Identify equipment upgrades and process improvements to boost yield and reduce cycle time.
• Perform equipment, process and product qualifications and validations (FDA-compliant).
• Lead efforts to scale and stabilize manufacturing processes.
• Conduct statistical analyses and report results per technical protocols.
• Serve as technical expert and perform root cause analyses for manufacturing issues.
• Manage projects including capital expenditures within budget.
• Handle purchasing, installation, and checkout of new equipment.
• Plan and document designed experiments to support upgrades.
• Ensure GMP compliance of equipment and processes.
• Support maintenance with engineering knowledge; document procedures.
• Uphold Coloplast ethics and policies; comply with laws and Advamed guidelines.

Skills

Manufacturing experience

Analytical skills

Project management

Continuous improvement

Problem solving

Statistical analysis

DFM knowledge

Cross-functional collaboration

Job description

Coloplast in Minnesota (Plymouth) is seeking a Senior Manufacturing Engineer to support implantable Interventional Urology manufacturing by developing and implementing procedures that maximize labor, material and equipment utilization while meeting regulatory requirements.

You will lead process improvements, perform validations, manage capital projects, and ensure GMP compliance. The role requires 5+ years in manufacturing, strong analytical skills, and proven project management capabilities.