The R&D Senior Mechanical Engineer primary purpose is to design a new product and improve exist designs, with emphasis on plastic parts and elastomers for injection with extensive orientation in medical products and standards. Activities will focus on variety of engineering tasks, including establishing requirements, assessing the suitability (risk, compliance) of current designs and technologies to meet the product requirements.
Major duties and responsibilities:
· Senior mechanical designer, specializing in injected plastic and elastomer parts, at the medical field.
o Design analysis
o Production and assemblies’ drawings including tolerance analysis.
o Operation and communication with suppliers in Israel and abroad
o Jig design and testing device, including assembly and test the device and prepare production portfolio.
o Work plans include task synchronization with electronics and software teams.
· Ensure compliance with procedural and documentation requirements of FDA and ISO design controls.
· Work with outside consultants and vendors.
· Leading the required design reviews.
· Identify and report technical risks.
· Project level analysis such as risk management, identifies resource gaps and works with the teams to resolve problems.
· Timeline, task, resources, and budget management – responsible for the development of timelines (Gantt charts) and processes for the engineering teams engaged in development, following engineering development phase methodologies.
Reports To: Mechanical Engineering Manager
Competencies:
· Comprehensive understanding in R&D of medical products
· Good understanding in the field of plastic and elastomer design.
· Experienced in the field of industrial design.
· Punctual, meets deadlines.
· Teamplayer who can also operate alone.
Education and Knowledge Requirements:
· B.DES. degree
· At least 10 years of experience in mechanical design, especially in the field of medical devices and plastics.
· Demonstrated experience developing departmental strategies and processes.
· Support test method and success criteria determination.
· Identify and reports technical and project risks.
· Strong technical orientation.
· Excellent communication skills with ability to deal effectively with all levels of management and ability to interface with other functional areas to ensure process and priorities are aligned.
· Demonstrated ability to multi-task, prioritize and work effectively under pressure.
· Good oral and written communication skills in English.
