Engineer Sr, Manufacturing Process

Position Overview

Support development and manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product processes; designing fixtures; and testing processes, equipment, and raw materials to ensure the concepts and/or prototypes meet their requirements. Create and/or support projects focused on development of process engineering and quality systems. Lead and/or support execution of projects related to capital equipment builds. Evaluate, initiate, and create improved engineering and project systems for procurement and execution of capital equipment builds. Provide engineering support in areas of mechanical design, manufacturing process development, and capital equipment assembly processes. Job duties:
  • Manufacturing support for existing processes and for new products, product changes, line extensions and enhancements, as well as related tooling and fixtures.
  • Support validation of product, equipment, and processes.
  • Interface with other departments to solve manufacturing production problems.
  • Monitor equipment maintenance program.
  • Investigate and test product processes.
  • Support prototype and Pilot Production, Facilities, and Planning when appropriate.
  • Lead manufacturing efforts associated with new product transfer between R&D and manufacturing.
  • Evaluate, create, and initiate improvements to existing engineering and project systems.
  • Provide support with execution of capital equipment build projects, including technical documentation (drawings, BOMs, specs, reports), builds procurement, and customer interaction.
  • Work closely with prototype lab and Machine Shop to provide clear documentation and communication and allow for efficient fabrication.
  • Develop documentation expertise related to equipment mechanical design and manufacturing processes.
  • Search and implement new technologies to improve manufacturing processes and equipment design.
  • Perform other duties and responsibilities as assigned.

Job Details

Job ID 10500BR

Aliso Viejo, California, USA

Salary Range:
$79,906 - $111,868

(Compensation could be higher based on education, experience and skill sets)

    • Bachelor’s degree in Engineering or related field.
    • Minimum of four (4) years of related experience.
    • Ability to read and prepare technical documentation.
    • Working knowledge of standard machine shop equipment and processes.
    • Knowledge of medical and technical development.
    • Proficient computer skills including MS Word, PowerPoint, Excel, and A-CAD or SolidWorks.
    • Ability to diagnose and repair electrical malfunctions on process tools and equipment.
    • Statistical knowledge.
    • Excellent written and verbal communication skills with ability to effectively manage internal and external customer relationships.
    • Ability to present proposals to end-users of technology, equipment, tools/fixtures to achieve user acceptance, and negotiate with customers and vendors.
    • Ability to work in a fast-paced, cross-functional environment.
    Desired Qualifications
    • Green Belt or Black Belt certification.
    • Ability to use and apply lean management principles to analyze, improve and create engineering project and quality procurement systems.
    • Experience working with manufacturing process development projects and transfer of R&D projects into high volume production.
    • Ability to prioritize and meet deadlines in a timely manner.