Manufacturing Engineer

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

Benefits offered by this job

Competitive compensation

Generous benefits package

Job summary

Trelleborg Medical Solutions in Delano, MN is seeking a Manufacturing Engineer to join our team, applying GMP and Lean Sigma to optimize production in a clean-room environment.

You will analyze product specifications, develop methods, and work with CAPA, DMR and ISO 13485 standards to deliver reliable, high-quality medical components.

This role offers a competitive salary in the US market plus a strong benefits package and opportunities for growth within a global leader.

Qualifications

• Bachelor's degree in Industrial, Manufacturing or Mechanical Engineering or related discipline.
• Medical device manufacturing experience is preferred.
• Strong English reading/writing/speaking ability.

Responsibilities

• Analyze product specs and translate into manufacturing processes and production rates.
• Identify tooling issues and coordinate with tooling suppliers to resolve them.
• Develop methods, establish labor standards, and cost information for products.
• Document processes in the company control system.
• Identify improvements and implement them to reduce scrap and improve throughput.
• Support Production, Engineering and Quality to meet delivery dates.
• Follow CAPA and participate in DMR disposition with VS team.

Skills

Lean manufacturing

Statistical analysis software

Communication skills

CAPA/8D problem solving

Education

Bachelor's in Industrial/Manufacturing/Mechanical Engineering

Tools

DOE methods

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.