דרושים » מדעים מדוייקים » Research Engineer (Msc)

our company is a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We are looking for an excellent Research Engineer to join the R & D team. Job Description Lead novel research in state-of-the-art technologies - bypass technological borders Lead departmental tasks that include problem solving and critical/root cause analysis Algorithms development for various system components Design and implementation of experiments for various projects Manage mutual research projects done and universities around the world

We are looking for an excellent Research Engineer to join the R & D team.

Job Description:
Lead novel research in state-of-the-art technologies - bypass technological borders.
Lead departmental tasks that include problem solving and critical/root cause analysis.
Algorithms development for various system components.
Design and implementation of experiments for various projects.
Manage mutual research projects done and universities around the world.


Direct Manager: Research director.

Eitan Medical is a fast-growing global medical device company, developing and manufacturing innovative drug delivery and infusion solutions across the continuum of care- from the hospital to the home. We are looking for an excellent Research Engineer to join the R & D team. Job Description · Lead novel research in state-of-the-art technologies - bypass technological borders · Lead departmental tasks that include problem solving and critical/root cause analysis · Algorithms development for various system components · Design and implementation of experiments for various projects · Manage mutual research projects done and universities around the world Direct Manager: Research director

Job Description:

supplier approval/disapproval including supplier maintenance and issuance of the Approved Supplier List.

Leading the SCARS process including SCAR initiation, SCAR follow up, Supplier investigation approval including root cause analysis and SCAR closure.

Leading the supplier audits process (including initial and surveillance audits) for critical suppliers, service centers, laboratories etc. by conducting on site / remote audits. Issuance and execution of the supplier audits plan including supplier audits follow up and supplier non-conformance follow up and response approval.

Support the execution of service agreements, quality agreements with suppliers and service centers.

Leading the supplier score card process, including trending.

Serve as Eitan Medicals CAPA Coordinator and Subject Matter Expert
Responsible and accountable for CAPA ownership, timely execution, and effectiveness of CAPAs. This includes creation, collaboration with functional teams on Problem Statement writing/Scope identification/Risk Assessment/Containment/Correction/CAPA plans/Verification of local and global compliance to CAPA procedures to ensure timely effective closure of CAPAs.

Generate data and key quality trending information for use in periodic reviews like Quality Metric Reviews and Management Review for CAPA and supplier processes.

Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements.
Write, update, release, and sign quality documentation within the Quality management system.

Direct manager: QA Compliance Manager

Responsibilities
Support the maintenance and organization of the Design History File (DHF) documentation.
Assist in completing documentation required for product releases in compliance with FDA, CE, ISO, and internal procedures.
Provide administrative support for design control activities throughout the product development lifecycle.
Support documentation related to software validation and traceability.
Assist in preparing documentation for audits and regulatory submissions.
Ensure documentation is accurate, complete, and properly filed in internal systems.

Review of Contract ,Customer SOW and SPEC requirements to ensure compliance of design and production.
Approve gates review at R&D
PLCM (Project Life Cycle Management) - process control, full partnership in project management during the development, testing, production, customer delivery and customer support phases throughout the product life
Identifying regulatory Gaps in new and carrent projects
Perform Internal and External Audits
QA presence in R&D process (capacity) and ability to prevent errors in design
Follow up after R&D corrective and preventive actions and Improvement Plans
Transfer products from development to NPI and serial production (QA activities)
Review and approval ECO / MCO / ATP/ATR, Waiver relate to R&D , ENG
Writing QA procedures
FRACAS Management
Quality Assurance Program Plan (QAPP) and the Quality Allocation Tasks for the program.
Customer complince - relate to NPI , Pre production , design errors
Perform Quarterly data analysis for QBR

Design of new, and support of existing airborne, marine and stationary pedestals to meet with environmental requirements.
Produce designs meeting performance, cost and manufacturability goals
Create fabrication and assembly drawings as well as related documentation
Support prototype assembly, assist in integration and test