30+ days ago


Tustin, CA


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


  • 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: