New Product Introduction Engineer

Role Description The New Product Introduction engineer will be responsible for all engineering activities related to product transfer to commercialization, including: documentation, mechanical components, assemblies, jigs, tools, and production-related equipment, while supporting engineering change activities, supplier-related technical issues, validation, and manufacturing readiness towards commercialization while working hand to hand with Engineering Product leader, R&D and Quality.

What will you do:

1.      Full responsibility for new product introduction management, method and process development,  engineering drawings, tooling design and production, equipment design and production related documentation (WI, BOM, DRW) and training.

2.      Author critical technical documentation, including PV (Process validation) protocols and reports, detailed engineering drawings, design review packages, and formal technical justifications.

3.      Conduct thorough failure investigations to establish root causes and deploy effective corrective actions.

4.      Manage and maintain DMR documentation.

5.      Support in design transfer of new products to production.

6.      Contribute to cost-reduction initiatives by redesigning manufactured parts and assemblies.

7.      Lead nonconformity and change control processes.

8.      Support suppliers in resolving product-related technical issues.

9.      Support maintenance activities for production-related equipment.

10.  Reports to: Engineering Director.

Education:

B.Sc. in Mechanical Engineering.

Essential requirements

1.      3+ years of experience as NPI engineer, preferably in the medical device field.

2.      Proficient in SolidWorks and PDM.

3.      Proven experience in manufacturing technologies (Machining, Sheet metal, Milling).

4.      Experience with CE and FDA regulations - an advantage.

5.      Experience with validation processes - an advantage.

6.      Experience with risk-based analysis and development processes – an advantage.

7.      Previous experience leading DFx (Manufacturability/Testability/Cost) activities.

8.      Previous experience leading PV (Process Validation, IQ, OQ, PQ) activities.

9.      Familiarity with best practices while working with subcontractors and manufacturers.

10.  Advanced knowledge of Medical Device Quality Systems and ISO 13485.

Skills:

1.      Fluent in Hebrew and fully proficient in English.

2.      Fast learner, independent, and responsible.

3.      Strong execution, communication, and interpersonal skills.

4.      Hands- Strong hand on mindset.

5.      Able to work effectively as part of a team.