Manufacturing Engineer — Medical Devices, Lean GMP

Trelleborg; Delano (MN); On-site; USD 75,000 - 95,000; Full time

Benefits offered by this job

Competitive compensation + bonusOpport

Generous benefits package: health, etc

Clean, climate-controlled environment

Impact life-saving devices

Growth and advancement

Job summary

Trelleborg Medical Solutions in Delano, MN, is seeking a Manufacturing Engineer to join our team. The role focuses on GMP-compliant process engineering in a clean-room environment, optimizing the value stream for medical components and devices.

You will translate product specs into manufacturing processes, develop labor standards, document processes, and drive improvements using Lean Sigma tools. The position offers a competitive salary and benefits, with opportunities to advance within a global

Qualifications

• Bachelor's Degree in Industrial, Manufacturing or Mechanical Engineering or related discipline.
• Medical device manufacturing experience.
• Ability to read, write, speak and understand English.
• Ability to communicate clearly and work effectively in teams.

Responsibilities

• Analyze product specifications and translate into manufacturing processes to establish production rates, quality levels and reliability.
• Identify tooling issues and work with tool makers to resolve them.
• Develop manufacturing methods, establish labor standards and compute product costs.
• Meticulously document all manufacturing process information in the document control system.
• Identify improvements and implement them quickly to enhance processes.
• Improve production rates and reduce scrap through new equipment or methods.
• Assist production in troubleshooting to meet delivery dates and quality.
• Review production schedules and engineering specs to resolve problems.
• CAPA - active member of CAPA team for permanent corrective actions.
• DMR - participate in product DMR disposition with the VS team.
• Follow ISO 13485 and 21 CFR 11/820 and the Trelleborg Quality System.
• Execute DOEs, problem solving, FMEA's, validations, control plans, and continuation engineering.
• Actively support Production, Engineering and Quality departments.

Skills

GMP experience

Lean manufacturing

Problem solving

Statistical analysis

Communication skills

English proficiency

Teamwork

Quality systems knowledge

Education

Bachelor's Degree in Industrial, Manufacturing or Mechanical Engineering

Tools

DOE methods

FMEA

CAPA tools

Job description

Trelleborg Medical Solutions in Delano, MN, is seeking a Manufacturing Engineer to join our team. The role focuses on GMP-compliant process engineering in a clean-room environment, optimizing the value stream for medical components and devices.

You will translate product specs into manufacturing processes, develop labor standards, document processes, and drive improvements using Lean Sigma tools. The position offers a competitive salary and benefits, with opportunities to advance within a global