Senior Manufacturing Engineer-Tustin, CA
Trelleborg is a world leader in engineered polymer solutions for almost every industry on the planet. And we are where we are because our talents brought us here. By specializing in the polymer engineering that makes innovation and application possible, Trelleborg works closely with leading industry brands to accelerate their performance, drive their business forward—and along the way, shape the industry and progress that will benefit humankind in the exciting years ahead.
Trelleborg Sealing Solutions US-Tustin, CA, is part of Trelleborg’s Healthcare and Medical Segment, we provide innovative quality medical device assembly and packaging, as well as engineering services and combination products to our customers. We are a USA ISO 13485-2016 certified company, with all services performed in California. Currently, there is an opportunity in our Operations Department, for a Senior Manufacturing Engineer.
TSS is an Equal Opportunity Employer and offers an excellent benefits package that includes:
• Life Insurance
• Health Insurance
• Vision Insurance
• Dental Insurance
• 401(k) plan
The Senior Manufacturing Engineer is responsible for the design and development of optimal engineering solutions for cost-effective lean manufacturing processes. Perform validation activities as necessary in a clean-room manufacturing environment. Recommends improvements to production processes, methods and controls. Supports and may manage manufacturing launch for new or revised products.
Responsibilities include:
- Analyzes product specifications and translate these into manufacturing processes to establish production rates, achieve expected quality levels and establish reliability of finished product
- Develops manufacturing methods for new and existing products, establishes labor standards and develop product cost information
- Performs validation activities as necessary in a clean-room manufacturing environment
- Engaged in research and development for equipment, processes, procedures and systems integration
- Meticulously documents all manufacturing process information and sequences within the site’s document control system
- Identifies opportunities for improvement to existing processes and methods using data or observation, develops the improvements and implements them as quickly as practical
- Makes improvements to production rates and reduces scrap by identifying and implementing new and better equipment, processes or human factor methods
- Assists production in troubleshooting production problems with individual components, individual processes and help improve the situation to assure customer delivery dates and superior quality
- Reviews production schedules and engineering specifications to resolve production problems.
- Serves as a member of the CAPA team, striving to implement permanent corrective actions.
- Participates in determination of product DMR disposition plan and approval
- Follows all H&M Quality System protocols including ISO 13485 and 21 CFR part 11 and part 820
- Execution of DOE's, problem solving, engineering studies, OQ/PQ validations, and continuation engineering for products
- 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
Qualifications:
- 4 year 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
- 10 years of experience in manufacturing engineering or related discipline
- Demonstrated leadership skills
- Medical device manufacturing experience
Desired:
- Master’s degree with concentration in Polymer Science
- Experience with medical silicone and/or component manufacturing
We welcome you to join our team during this exciting time!
Apply using this link: https://bit.ly/3iCvdFW