Engineering & Operations Manager

Engineering manager will have the overall responsibility for all engineering and operation aspects of product development and manufacturing processes, and ensuring meeting the quality requirements, and product supply according to company plans.

Responsibilities:

Create and implement best practice engineering vision, strategy, processes, procedures and systems to meet company’s plans

Lead the engineering team, manage working and manufacturing plans

Overall responsibility for all DMRs aspects including work instructions, drawings, inspections, BOMs and configuration management

Overall responsibility for all ECOs projects

Lead process validation activities and test method validations (IQ, OQ, PQ, TMV)

Lead process scale up and process improvement projects

Overall responsibility for production processes and controls including work instructions and inspections, assembly jigs and fixtures, non-conforming material disposition, testers, obsolescence management etc.

Manage subcontractors and vendors, manage materials supply

Lead material Review Board (MRB),

Lead production investigation failure and root cause analyses

Requirements:

B.Sc. or M.Sc. degree in Mechanical Engineering

7-10 years proven experience in engineering environments of medical device.

Professional experience in design and assembly of medical device, in clean room environment

Minimum of 1-3 years relevant managerial experience of leading an engineering team

Proficient with SolidWorks

Experience in ERP, PLM, PDM tools.

Knowledge of standards and regulatory: ISO 13485, CFR21

Hands On

Excellent written and verbal communication skills (Hebrew + English)