Manufacturing Engineer

Trelleborg•Delano, MN

65d•$75,000 - $95,000•Onsite

About The Position

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

Requirements

Bachelor’s Degree in Industrial, Manufacturing or Mechanical Engineering or related discipline
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
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.

Nice To Haves

Medical device manufacturing experience
injection molding experience

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.
Active member of the CAPA team responsible for implementing permanent corrective actions.
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.