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
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
- 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
- Phone Screen
- Face to Face : interview Manager & HR
- Workshop & CorWave Management interviews
- Reference check
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
Please send your CV to: firstname.lastname@example.org, reference « NPI SE EN ».