Senior Medical Device Manufacturing Engineer | Lean Sigma

Trelleborg Sealing Solutions Switzerland AG; Delano (MN); On-site; USD 95,000 - 123,000; Full time

Job summary

Trelleborg Medical Solutions in Delano, MN is seeking a Senior Manufacturing Engineer to support GMP-compliant manufacturing operations in a clean-room environment. You will apply engineering theory to optimize the value stream for specific products using Lean Sigma tools and lead manufacturing initiatives.

The role requires a Bachelor's in Industrial, Manufacturing or Mechanical Engineering, Lean Sigma Green or Black Belt, and at least 7 years of manufacturing engineering experience, plus

Qualifications

• Bachelor’s degree in Industrial, Manufacturing or Mechanical Engineering or related discipline.
• Lean Sigma Green or Black Belt certification.
• Polymer Science, Lean Kaizen or other specialized background.
• 7 years of experience in manufacturing engineering or related discipline.

Responsibilities

• Analyze product specifications and translate these into manufacturing processes to establish production rates, achieve expected quality levels and establish reliability of finished product.
• Identify tooling related issues and communicates/works with a tool maker to resolve the issues
• Develop manufacturing methods for new and existing products, establish labor standards and develop product cost information.
• Meticulously document all manufacturing process information and sequences within the Trelleborg document control system.
• Identify opportunities for improvement to existing processes and methods using data or observation. Develop the improvements and implement them as quickly as practical.
• Make improvements to production rates and reduce scrap by identifying and implementing new and better equipment, processes or human factors methods.
• Assist production in troubleshooting production problems with individual components, individual processes and help improve the situation to assure customer delivery dates and superior quality.
• Review production schedules and engineering specifications to resolve production problems.
• CAPA- Active member of the CAPA team responsible for implementing permanent corrective actions.
• DMR- Participate in determination of product DMR disposition plan and approval with the VS team.
• Follow ISO 13485 and 21 CFR part 11 and part 820 and Trelleborg Quality System protocols.
• Execution of DOE's, problem solving, FMEA's, validations, control plans, continuation engineering for products.
• Actively Support Production, Engineering and Quality departments.
• Mentors Manufacturing Engineers and Technicians through experiences and education as opportunities arise
• Develops ideas and strategies to improve operational efficiency, add value, aid business performance and work towards a culture of continuous improvement.
• Successfully manages multiple high-profile projects simultaneously

Skills

Lean Sigma

Leadership

Project management

Problem solving

Communication

Metrology

DOE / FMEA

Statistical analysis software

Microsoft Office

Education

Bachelor’s degree in Industrial/Manufacturing/Mechanical Engineering

Lean Sigma Green or Black Belt certification

Polymer Science / Lean Kaizen background

7 years experience in manufacturing engineering

Tools

Microsoft Office

Statistical analysis software

Job description

Trelleborg Medical Solutions in Delano, MN is seeking a Senior Manufacturing Engineer to support GMP-compliant manufacturing operations in a clean-room environment. You will apply engineering theory to optimize the value stream for specific products using Lean Sigma tools and lead manufacturing initiatives.

The role requires a Bachelor's in Industrial, Manufacturing or Mechanical Engineering, Lean Sigma Green or Black Belt, and at least 7 years of manufacturing engineering experience, plus