Senior Engineer New Product Industrialization (NPI) M/W

Job description

The New Product Industrialization Senior Engineer, is responsible to design, develop and qualify manufacturing processes, equipment and tooling to deliver a product consistently within specification.

Is a subject matter expert with medical device processing techniques, equipment, and materials. Your responsibilities will cover the following :

  • Design, develop and validate manufacturing processes, equipment and tooling to meet Product Specifications.
  • Accountable for process and manufacturing requirements based on Product Specifications and Test requirements from R&D
  • Accountable for establishing Inspection and Test Criteria for manufactured assemblies
  • Carry out the specification and procurement for Capital manufacturing equipment
  • Ensure adherence to the applicable process for product introductions, qualifications and process release to production
  • Provides Manufacturing input into design process focusing on DfX
  • Apply LEAN manufacturing principles to arrange production line layout and balance workflow
  • Participate in project reviews to support product development activities
  • Interface with vendors on component manufacturing issues & process validations
  • Participate in analysis and facilitate resolution of production & technical issues, including root cause identification and re-occurrence prevention.
  • Drive change management impacting manufacturing process documentation, product structure MBOM, product/component specification changes & improvements

Qualifications

Engineer’s Degree in Engineering and 5 years relevant work experience with multiple manufacturing processes (e.g. sterile packaging, cleaning, sterilization, machining, assembly)

Knowledge of the Class III medical device environment is a strength.

In order to succeed in this position, you have the following skills and experience:

  • Working knowledge of process validation (pFMEA, IQ, OQ, PQ)
  • Familiar with FMEA, 8D, SPC, A3, Lean Manufacturing
  • Familiar with ISO13485 and FDA 21CFR820
  • You have a strong team spirit, you are autonomous and rigorous. You will be able to demonstrate effective leadership and flexibility. You are able to interact in a multicultural environment.

    Your level of English is fluent in both spoken and written English.

      Compensation and logistics

      • Position to be filled as soon as possible
      • Competitive salary based on skills and experience
      • Executive (cadre) status with day package
      • Contact type: full-time permanent contract (CDI)
      • Location: Paris area, Clichy-Levallois (métro ligne 13, train L 6 min de Saint Lazare)
      • Food allowance with a Swile card
      • 50% reiumbursement of your Navigo pass & bike bicycle mileage costs
      • Health insurance (« complémentaire santé ») Malakoff Humanis
      • Complementary collective insurance scheme (« prévoyance »): Malakoff Humanis (100% funded by CorWave)
      • International environment
      • Recruitment process

        • Phone Screen
        • Face to Face : interview Manager & HR
        • Workshop & CorWave Management interviews
        • Reference check

        Please send your CV to: careers@corwave.com, reference « NPI SE EN ».