About this role
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