Manufacturing Engineer

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

• Pay or shift range: $75,000 USD to $95,000 USD
  The estimated range is the budgeted amount for this position. Final offers are based on various factors, including skill set, experience, location, qualifications and other job-related reasons.

Description

Don’t let the Delano address fool you! Our facility is conveniently located just 20 minutes from Maple Grove, 25 minutes from Lake Minnetonka, 30 minutes from Plymouth, and 40 minutes from downtown Minneapolis. Many of our employees enjoy a straightforward commute from across the west metro while avoiding heavier city traffic.

Trelleborg Medical Solutions is seeking aManufacturing Engineer to join their team in Delano, MN. Follows good manufacturing practices (GMP) and principles to provide engineering support and develop robust manufacturing processes. Has a primary role in the engineering of new, modified and/or existing manufacturing operations in a clean-room environment. Apply engineering theory and principles to ensure that the Value Stream for specific products is optimized using Lean Sigma tools.

Responsibilities:

• Analyze product specifications and translate these into manufacturing processes to establish production rates, achieve expected quality levels and establish reliability of finished product.
• Identifies 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.

Education and Experience Requirements:

• Bachelor's Degree in Industrial, Manufacturing or Mechanical Engineering or related disciplinE
• Medical device manufacturing experience
• Ability to read, write, speak and understand the English language
• Ability to communicate clearly by conveying and receiving ideas, information, and direction effectively
• Ability to demonstrate adequate job knowledge to deliver a world-class performance
• Ability to challenge oneself to consistently meet all goals and deadlines
• Willingness to strive for excellence by producing work that is free of errors and mistakes
• Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately
• Commitment to making improvements company-wide
• Use of statistical analysis software
• Interpersonal skills and good communication technique
• Ability to coordinate multiple projects and deadlines, manage and identify the scope
• Lean Manufacturing- Proficient in the use of problem-solving tools such as 5 why, Fishbone, 8D, etc.
• Understanding of manufacturing processes for medical components and devices.
• Good understanding of metrology principles and methods.

Salary Range $75,000-95,000/year based on experience

As a valued team member with Trelleborg, you will enjoy:

• Competitive compensation: Plus, bonus opportunities!
• Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
• Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!
• Greater opportunity for impact: You will impact the production of life-saving devices.
• Growth and advancement: Join a global company that loves to promote from within and allows for advancement.

Qualifications

Education

Preferred

Bachelors or better.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.