Manufacturing Process Engineer

3 hours ago


Waltham, Massachusetts, United States firstPRO, Inc Full time

Job Summary:

We are seeking a highly skilled Manufacturing Process Engineer II to join our team at firstPRO, Inc. in Waltham, MA. This individual will play a key role in supporting the daily technical activities of planar sensor manufacturing, developing and optimizing manufacturing processes to achieve increased output, quality, and cost goals.

Key Responsibilities:

  • Investigate and resolve technical issues that arise during manufacturing/processing of products.
  • Measure and inspect components for form, fit, function, and disposition nonconforming product.
  • Document variances/changes and circulate for approval.
  • Update/create manufacturing documentation (AP, TP, OI, OP, Drawings, and Artwork) conforming to Quality System Regulations (QSR's) and ISO standards.
  • Write and/or execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA), Process Validation Master Plans, and Continuous Improvement Studies/Evaluations.
  • Research, specify, and procure new equipment for existing or new processes/assemblies.
  • Design and construct tooling/fixtures for processes or modify existing production equipment as needed.
  • Collaborate with R&D and other manufacturing engineers to develop methods/processes to scale production and implement new products.
  • Train assemblers and operators regarding new processes and assemblies.
  • Lead continuous improvement programs to reduce cost and cycle times of products.
  • Examine and implement lean manufacturing techniques.
  • Work cross-functionally with Consumable Engineering for automation and longer-term projects as appropriate.

Qualifications:

  • Physical Requirements:
  • Hearing.
  • Remaining in a stationary position, often standing or sitting for prolonged periods.
  • Ability to wear PPE.
  • Ability to travel.
  • Knowledge of lean manufacturing methods and practices.
  • Six Sigma Green Belt (Preferred).

Skills/Competencies:

  • Strong interpersonal and communication skills.
  • Strong Project Management Fundamentals.
  • Time Management skills.
  • Six Sigma.
  • Lean Manufacturing Principles.
  • Minitab (Other statistical and graphical analysis applications).

Education/Experience:

  • B.S. in Mechanical Engineering or Industrial Engineering is required.
  • 2-4 years of experience in an ISO 13485 environment is required.


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