Job Title: Lead System Engineer
Location: Caesarea, Israel
Reports to: Director of R&D
Job Description: The Lead System Engineer will lead a group of System Engineers to drive adoption and integration of System Engineering methodologies to improve product outcomes.
Note: The following meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.
Key Responsibilities & Authorities:
Responsible for all Risk Management activities:
- FMEA, Risk analysis, Risk Management Plan/File/Report, mitigations
- Cross functional risk management support, training and audit representation
- Development of system architecture and requirement
- Grow System Engineering competency within the organization
- System and Integration level investigations and defect management, including usage of standard investigation methodologies (e.g. 5Y, Fishbone analysis)
- Control and define system configurations including End Of Life
- Define requirements for Reliability, Serviceability, manufacturing, storage and shipment.
- Lead process to ensure compliance with latest versions of applicable standards throughout the product development life cycle. Engineering related standards (e.g. 60601 4th edition and related EMC impact).
- Overall responsibility for training and qualification of team members
- Performing employee’s development plan includes Management By Objectives and annual feedback process.
- Compliance to Medical Device industry requirements.
BSc.in Electronics/HW/SW/Mechanics/ Physics from a well-known university MSc. in System Engineering
Minimum 5 years of System Engineering experience in the Medical Device industry Lead System Engineer experience – mandatory Managerial experience – advantage
Job Specific Skills (Languages, SW, systems, etc.'):
Understanding of structure and methodology of: RMF, Requirements, Investigations, V&V
Excellent communication skills, written and verbal (Hebrew and English) Solid organizational skills including attention to detail and multi-tasking skills
Other Requirements for the role (% of travel, etc.):
Ability to work in a team minded approach to achieve individual and company success. Able to confidently deal with ambiguous issues and provide input towards suitable actions. Self-learning abilities
Internal: Requires interface with all Mazor departments: all project team members including engineering (mechanical, electrical, software, systems, and test), quality, regulatory, marketing, technical communications, end users, technical support, production, and suppliers.
External: Suppliers, Manufacturers, Customers