CorWave is a medical technology start-up, currently in pre-clinical stage, developing biomimetic implantable heart pumps with the mission to improve the lives of patients with advanced heart failure. The CorWave corrugated membrane pump is a disruptive technology protected by over 50 patents and the result of 20 years of research. Funded by leading international investors, supported by renowned surgeons, and with over 70 employees from nearly 10 different nationalities, CorWave aims to become a global leader. The “EPIC” values are at the heart of the company’s success and drive the CorWavers in this scientific, medical, industrial and deeply human adventure: Team spirit, Perseverance, Innovation and Trust.
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
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
- Phone Screen
- Face to Face : interview Manager & HR
- Workshop & CorWave Management interviews
- Reference check
Please send your CV to: firstname.lastname@example.org, reference « NPI SE EN ».