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
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:
- Prequal interview
- Interview with Manager
- Workshop & HR interview
- Reference checks