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.
- 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
- 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
- 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