Title: Manufacturing/Process Engineer

General Summary

The Manufacturing/Process Engineer is responsible for supporting manufacturing processes, with an emphasis on Lean Manufacturing systems and waste elimination. Key responsibilities include optimizing manufacturing process flows/Value Stream Mapping, plant floor layouts, developing manufacturing cells, and implementing lean manufacturing techniques to reduce scrap, eliminate waste, and improve labor utilization.

Essential Duties and Responsibilities include the following. NOTE: Other duties may be assigned.

  • Analyze manufacturing process flow and floor layout to enhance safety, quality, and efficiency; utilizes Lean Manufacturing/Six Sigma techniques to lead the verification/validation and implementation of process improvements to drive efficiency and eliminate waste;
  • Development, implement, and verify/validate manufacturing cells in support of process flow and Value Stream Mapping improvements, or in support of New Business Development initiatives;
  • Leads the Single Minute Exchange of Die initiatives, reducing changeover times and complexity, and accountable for efficient, effective job change start-ups;
  • Maintains the Standard Operating Setup Sheet library; verifies deviations to setup and monitors line and product performance following such changes;
  • Assists the Product Development and Manufacturing teams with new tool qualifications, as necessary.Education and Experience
  • BS in Engineering;
  • 5+ years’ experience in a medical device manufacturing environment, or similar regulated industry;
  • Preference to candidates with an ISO 13485 background, experience with capital expenditure projects, six sigma experience, and proficiency with SolidWorks;
  • Secondary process experience including plastic manufacturing, and automation controls and hardware highly desirable.

Skills and Abilities

  • Hands-on expertise with Lean Manufacturing/Continuous Improvement tools to drive efficiency and eliminate waste;
  • Experience identifying/implementing Single Minute Exchange of Die (SMED)/quick changeover initiatives;
  • Good interpersonal skills with demonstrated ability to function successfully in team environment; able to lead/collaborate with team members and gain buy-in through effective communication and team-oriented problem solving;
  • Effective listening and good communication skills (verbal/written), ability to issue clear instructions;
  • Good problem solving and conflict resolution skills;
  • Ability to comprehend and retain working knowledge of complete product line;
  • Ability to multi-task and respond to changing priorities;
  • Ability to promote and encourage process improvement initiatives to department staff.Physical Demands
    The work environment is that found in a light production, warehousing, shipping setting with primarily overhead lighting. The facility is temperature controlled, and the air quality is good. At times, individual will need to transition in and out of “clean room” production portion of space.

    Work Environment

  • Individual will need to sit (at times for extended periods) or stand as needed. May require walking primarily on a level surface during the workday. Reaching above shoulder heights, below the waist or lifting as required to move materials and equipment during the workday. Ability to lift up to 50 pounds using proper lifting techniques.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Reports To: Vice President of Operations

Department: Operations

FLSA Status: Salary Exempt

Shift: 1st Shift