Process Engineer

4 weeks ago

Irvine, California, United States Masimo Full time
Job Title: Process Engineer

Join Masimo as a Process Engineer and contribute to the development, improvement, and validation of new and existing manufacturing processes, equipment, tooling, and fixtures.

Key Responsibilities:
  • Develop and implement World Class Manufacturing capabilities for Masimo's products.
  • Design, specify, purchase, install, and qualify manual and automated assembly equipment and tooling.
  • Collaborate with design engineering to influence designs for better manufacturability.
  • Develop manufacturing plans, project timelines, requirements, specifications, and process flow.
  • Generate Manufacturing Assembly and In-Process Acceptance Procedures and train production personnel.
  • Develop Validation Master Plans and perform process validations (IQ, OQ, PQ) including generating protocols and reports.
  • Perform line setup, line balancing, and build time studies.
  • Lead initial product builds (engineering units, pilot units, process validation units) and coordinate a smooth transfer of new products into production.
  • Develop Process Failure Mode and Effects Analyses (PFMEAs).
  • Conduct Design Reviews and prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of projects in progress on a regular basis.
  • Establish Statistical Process Controls for Manufacturing Operations.
  • Support satellite manufacturing plants through effective communication.
  • Drive continuous improvement of engineering technical capabilities.
  • Continuously research, learn, and recommend best practices for world-class manufacturing.
  • Travel domestically and internationally as required.
Requirements:
  • Experience with optical/electro-mechanical assembly and testing.
  • Experience in modern manufacturing principles and techniques.
  • Working knowledge of statistical techniques (e.g., DOE, SPC).
  • Experience in process automation, verification, and validation.
  • Excellent communication skills and technical writing abilities.
  • Excellent conceptual, analytical, and problem-solving abilities.
  • Excellent computer skills - Solidworks (CSWA), word processing, and spreadsheets.
  • Ability to work effectively in cross-functional teams.
Preferred Qualifications:
  • Proven experience in taking a major device from inception to customer shipment.
  • Proven work experience in process engineering.
  • Working knowledge of 21 CFR, Part 820 and ISO 13485:2003 requirements.
  • Ability to integrate new technology into an existing business environment.
  • Experience with design, development, and validating manufacturing processes for an optical/electro-mechanical device containing software.
  • Experience with cable assembly processes including cable preparation, hand soldering, crimping, etc.
  • Experience with plastic injection molding.
  • Excellent CAD (Solidworks) skills, CSWP.
  • Working knowledge of Geometric Dimensioning and Tolerancing (GD&T).
  • Demonstrated ability to manage large-scale projects and deliver results on time and within budget.
  • Design experience (ability to design for manufacturability).
  • Basic device software knowledge.
Education:

Bachelor's degree in engineering: Mechanical, Electrical, Manufacturing, or Industrial Engineering or related field is required.

Compensation:

The anticipated range for this position is $93,000 - $139,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

Work Environment:

This position primarily works in an office environment. It requires frequent sitting, standing, and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities.

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