Product design owner Engineer

Position Summary:
·  Own the engineering aspect of the product design history file (DHF)
·  Approve, Consult, Manage engieering changes, and execute where applicable both hardware and software  of the product
·  Supervising and executing sustaining product engineering changes (ECO), administration, and communication of Quality Assurance (QA) activities with relevant regulatory requirements for medical devices.
 Reports to- Head of SW with dotted line to Head of Engineering and Operations
 Key Responsibilities:
·  Leads all technical aspects of the product
·  Sustaining product
·  Manages and Executes ECOs   
Reviews and approves Design History Files   
Support the Sales, Service and Marketing teams questions.   
Writes, reviews, revises and approves documentation (including drawings) for consistency and compliance with good documentation practices, QMS and regulatory requirements, such as: Incoming inspection of raw materials packaging and labeling materials.   
Supports supplier qualification and evaluation, communication of quality issues and monitoring of trends. Support suppliers in resolving production quality issues and quality improvements.   
Supports quality Internal audit and External audits by regulatory agencies.
·  Supports complaint handling process .
 Skills and Competence:
 Past experience in a regulated industry, medical device filed is preferred   
Past engieering experience in at least two areas of the folwoing  – Electronics Hardware developmet, Embedded SW, Mechncial design    
Demonstrates knowledge of 21CFR Part 820 and ISO certification (ISO 13485 (EN ISO), MDSAP, ISO 9001) – advantage   
Strong knowledge of manufacturing operations and cGMPs    
Strong interpersonal, organizational, communication skills   
Effective problem solving skills   
Excellent verbal and written communication skills   
Proficiency in English and Hebrew   
Ability to engage and motivate others   
Orgenized and able to follow a detailed process
 Education
·  B.Sc in Electical/Mechanical engineering or equivalent is a must .
 Work Experience
·  Minimum 5 years of experience in a regulated industry, medical device filed is preferred.
·  Experience in writing and editing ECO
·  Experience in working with QA activities such as: process and change control
·  Experience in owning a processes from A to Z