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 Competencies • 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