Manufacturing Engineer

Johnson & Johnson Johnson & Johnson · Pharma · Santa Clara, CA +1

Manufacturing Engineer NPI role focused on launching new products, specifically robotic assembly and test equipment for medical devices. Responsibilities include specifying, qualifying, validating, and troubleshooting equipment and processes, collaborating with cross-functional teams, and ensuring compliance with regulatory standards like GMP and ISO 13485. Requires a BS in a technical field and experience with electromechanical systems, process development, validation, and risk assessment.

What you'd actually do

  1. Specifying, procuring, qualifying, validating, troubleshooting, and maintaining process and test equipment and manufacturing and test procedures needed for robotic assembly and test
  2. Supporting investigations to determine root cause of failures, presenting results, and proposing corrective and preventative actions as required
  3. Using capabilities, such as Lean/Six Sigma, DFx, SPC, etc, to improve company knowledge, products and processes
  4. Collaborating and interacting with other company engineering teams, including R&D, Product Quality, Regulatory, and Supplier Quality
  5. Providing engineering, risk assessment, and statistics support in the development and maintenance of the company’s quality systems

Skills

Required

  • Bachelor of Science Degree in a technical field
  • proficiency and familiarity in electromechanical systems
  • experience with process development activities
  • Experience with Process Validation (IQ/OQ/PQ), SW Validations, and/or Test Method Validations (TMV)
  • Experience with conducting Product Risk Assessment and Product Risk Analyses (FMEA)
  • Ability to read engineering drawings and schematics
  • Proficiency and knowledge with electrical test equipment
  • Ability to author and release Engineering Change Orders (ECOs) and manufacturing documentation

Nice to have

  • Experience in Medical Device Quality Management Systems and industry GMPs and standards
  • Proficiency in statistical techniques, statistical process controls (SPC)
  • Produce high quality documentation
  • Experience in Product Lifecycle Management systems such as Oracle Agile
  • Experience working on instrumentation automation and using scripting languages such as Python, Shell, Batch, Bash or Linux commands
  • Knowledge of LEAN/Six Sigma and Process Six Sigma
  • Ability to demonstrate familiarity in Statistical Process Controls (SPC)
  • Familiarity with manufacturing and production systems such as ERP, MES, PLM

What the JD emphasized

  • robotic assembly and test
  • process and test equipment
  • manufacturing and test procedures
  • electro-mechanical components and subassemblies of medical robotic systems
  • process validation (IQ/OQ/PQ)
  • test method validation (TMV)