New Product Introduction Engineer

Who are we?

We are here to improve lives by restoring sight worldwide by a robotic platform for vision saving surgery. Our company will improve the way ophthalmic surgery is delivered to vision impaired individuals now and for decades to come.

We are rapidly growing, funded by leading international VCs, and are looking to expand our small, motivated, multi-disciplinary and phenomenal team. Joining us is an opportunity to work towards saving vision across the globe, collaborating with others to realize a dream, and tackle an enormous challenge that will help drive your career forward.

Job Description/Responsibilities

• Responsibility for transfer from development to production.
• Configuration management and Implementation of Engineering Changes.
• Construction and management of product DMR including BOM, SOP's, Mechanical & electrical specs.
• Leading DFx and ATP processes (Design for manufacturing, testing, cost optimization).
• Design & qualifications of assembly & test fixtures/Jigs and tools.
• Support on-going production processes and equipment, train subcontractors & production.
• Design and implement product improvements.
• Leading ECR & ECO Implementation processes.
• Leads process risk assessment, i.e., pFMEA.
• Process Validations and qualification of equipment IQ/OQ/PQ.
• Creating work and testing instructions, production, and assembly instructions.

Qualifications:

• BSc. in Mechanical engineering
• At least 7 years experience in design, engineering, transfer of multi-disciplinary products from development to production in Medical Device companies - Mandatory.
• Proficiency in SolidWorks – Mandatory.
• Experience with design of Jigs, fixtures, Process Validations and qualification of equipment IQ/OQ/PQ.
• Prior experience with some of the following: complex machined parts, sheet metal, plastics, cable assemblies, PCBA.
• Office proficient, experience with PDM/PLM systems, Priority.
• Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD.
• Able to manage multiple tasks, team player and excellent in human interfaces.
• Excellent communication skills, both verbal and written in English & Hebrew.