Senior Manufacturing Engineer

Trelleborg Medical Solutions is seeking a Senior Manufacturing 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. Senior Manufacturing Engineer: including all the above 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 Education and Experience Requirements 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 Demonstrated leadership skills 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 Demonstrated competence using Microsoft Office Use of statistical analysis software Interpersonal skills and good communication technique Ability to coordinate multiple projects and deadlines, manage and identify the scope Act as a project leader on major projects 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 $95,000 - $123,000 based on experience 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. #J-18808-Ljbffr Trelleborg Sealing Solutions US Inc