New Product Introduction Engineer

Who we are:

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.

Responsibilities:

• Responsibility for design 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., CAPS LOCK.
• 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 5 years’ experience in design, engineering, transfer of multi-disciplinary products from development to production in Medical Device companies - Mandatory.
• Proficiency in SolidWorks – Mandatory.
• Proven experience in designing jigs, fixtures, and conducting process validations and equipment qualification (IQ/OQ/PQ).
• Experience with some of the following: complex machined parts, sheet metal, plastics, cable assemblies, PCBs.
• Proficient in Microsoft Office, Priority ERP, and PDM/PLM systems. Experience with Windchill PLM is an advantage.
• Strong knowledge of relevant medical device regulations and standards, including FDA QSR, ISO 13485, ISO 14971, and MDD.
• Able to manage multiple tasks, a team player with excellent interpersonal skills.
• Excellent communication skills in both verbal and written English and Hebrew.