Senior Manufacturing Engineer

1 month ago

Westminster, United States Highridge Medical Full time

Sr. Manufacturing Engineer Job Summary:

The senior manufacturing engineer is responsible for providing manufacturing engineering services to support efficient manufacturing processes. Engineering services may include supplier and internal manufacturing support, process development, identifying and managing strategic operations projects, process validation, inspection design and methodology, optimizing cost processes and trouble shooting.


Principal Duties and Responsibilities:

  • Work closely with design, production, quality, and procurement teams to ensure seamless integration of manufacturing and operations processes
  • Assist the Quality and Supply Chain departments to evaluate new suppliers and assist with production transfers
  • Creating, maintaining, and improving controlled technical documents such as prints, procedures, bill of materials, inspection plans and routers
  • Supporting a wide variety of processing applications such as machining, finishing, forging, casting, cleaning, heat treating, bonding, packaging, etc.
  • Conducting feasibility study to estimate product cost and analyze capital equipment, capacity, and capability requirements
  • Establishing and improving process methods which meet performance and quality requirements
  • Developing and executing project plans and schedules for work activities
  • Communicate (written and verbal) direction and project plans with appropriate personnel from other departments.
  • Scope and execute equipment qualification or process validation project(s)


This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA.



Expected Areas of Competence (i.e., knowledge, skills, and abilities)

  • Skilled and knowledgeable in manufacturing and new product processing
  • Competence with drafting standards and geometric dimensioning and tolerancing
  • Proficiency in CAD software
  • Ability to balance marketing, manufacturing, and design requirements to meet customer requirements
  • Ability to lead and prioritize multiple medium complexity project assignments and complete work in a timely manner
  • Good problem solving skills through the use of quality and statistical tools
  • Ability to effectively work within a cross-functional team to complete critical project tasks
  • Demonstrates good written and verbal communication skills
  • Experienced with control procedures, such as the Change Management System, Nonconformance Reports, Engineering Specifications, Corrective and Preventive Action (CAPA), and Work Instructions
  • Proficient with Statistical Process Control concepts, process development, process validations, DFx, inspection methodology and project management tools
  • Microsoft Office Suite and Project


Education/Experience Requirements

  • B.S. in engineering with a minimum of 5-7 years of manufacturing engineering experience. Or other technical or advanced degree plus 7 years of experience in an engineering or technical role.
  • Knowledge in Lean Principles and or Six Sigma or other problem solving methodology is preferred.
  • Understanding of medical device industry or other regulated industries.


Travel Requirements

Up to 10%

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