Trelleborg Medical Solutions · 1 day ago
Senior Manufacturing Engineer
Delano, MN
Full-time
Onsite
Mid, Senior Level
$95K/yr - $123K/yr
7+ years expTrelleborg Medical Solutions partners with leading medical device and biopharmaceutical companies to improve patient quality of life. They are seeking a Senior Manufacturing Engineer to provide engineering support and develop robust manufacturing processes while optimizing production using Lean Sigma tools.
Medical Device
Hiring Manager
Gabrielle Gutzwiller
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
Qualification
Required
Bachelor's Degree in Industrial, Manufacturing or Mechanical Engineering or related discipline or equivalent combination of education and experience
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
Company
Trelleborg Medical Solutions
Trelleborg Medical Solutions partners with the world’s leading medical device and biopharmaceutical companies, collaborating from concept to commercialization to bring to market impactful solutions that improve patient quality of life.
1001-5000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase