Lead Engineer New Product Industrialization (NPI) M/W

Job description

The New Product Industrialization Lead 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
  • Support 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
  • Complete assigned tasks to meet established time frames
  • Interface with vendors on component manufacturing issues & process validations
  • Supports investigation & facilitates resolution of production & technical issues including root cause identification and re-occurrence prevention.
  • Drive change orders impacting manufacturing process documentation, product structure MBOM, product/component specification changes & improvements
  • Performs other related duties and responsibilities, as assigned

Qualifications

Minimum Master of Science degree in one of the following engineering disciplines: Mechanical Engineering, Biomedical Engineering, Industrial or similar and 3 years relevant work experience in medical device 

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, 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 (Range 45-50K total salary)
  • Executive (cadre) status with day package
  • Contact type: full-time permanent contract (CDI)
  • Location: Paris area, Clichy
  • 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

 Applications to send to:

 careers@corwave.com 

Recruitment process

  • Prequal interview
  • Interview with Manager
  • Workshop & HR interview
  • Reference checks