לוח משרות דרושים מהנדסי מכונות בחיפה וסביבתה

This position is responsible for designing and developing new and improved manufacturing processes and ensuring efficient and effective product transfer into production within the medical disposable devices industry.  Improve existing processes and implement new processes in the production line.

Job Responsibilities:

Develop and implement new manufacturing processes for production.

Perform Design of Experiments for process definition and optimize equipment parameters for new and/or existing processes.

Create documentation to support new and improved manufacturing processes.

Write and perform process validations (IQ, OQ, PQ) and validate methods for inspection, verification, and process controls.

Interface directly with assemblers, production supervisors, leads, and engineers.

Assesses process capabilities, innovates, and implements process improvements on key projects.

Applies technical knowledge to innovate, design, and develop processes, procedures, tooling, and/or automation.

Executes the functional deliverables associated with the NPI, Design Control, CAPA, and all Quality Systems.

As needed; plan, organize, and participate in all aspects of technical reviews.

Collaborate to ensure proper documentation is completed to meet quality systems requirements. (e.g., GOIs, BOMs, Routers, FMEAs, etc.).

To Equipment Engineer will be responsible to engineer and implement highly capable & effective manufacturing equipment to meet business goals and objectives.

Key Responsibilities:
Responsible for developing testing and manufacturing equipment.
Create mechanical designs and drawings using Solidworks according to department standards and company procedures.
Ensure relevant documentation is prepared in line with all Quality and Regulatory guidelines and promotes full compliance with all GMP & E&AS
Identifying and solving the root cause of complex technical issues with production equipment.
Writing and execution of equipment qualifications, protocols, and reports.
Implementation of equipment into the production lines.

We are looking for a System Verification Engineer.
About The Position:
Define System Verification based on System (SW/HW) Design Inputs:
Study design/reliability requirements.
Take part in design reviews.
Define and execute feasibility experiments for proof of concept/design.
Establish Verification Equipment, Verification Methods and Infrastructure:
Define, develop, and maintain testing equipment and methods to provide the means to execute verification.
Collect and analyze data for improvement of methods/processes.
Plan and execute Design Verification and Process Validation for:
Developed products and processes.
Engineering Change Orders.
Service/Manufacturing equipment and processes.
Prepare and release Verification Reports:
Based on collected, analyzed data vs. pre-defined acceptance criteria.
In compliance with companys QMS and applicable standards/regulations.
Participate in the following forums:
Design reviews
Product development gates and milestones.
Initiate, manage, and monitor external testing contractors, such as Testing Houses and Labs.
Define and prepare testing to be performed by external contractors.
Identify and study relevant standards and guidelines (e.g. transportation/shelf-life standards).
Track, review and approve external testing reports.
Working according to Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.

We are seeking an experienced and highly motivated System Development Engineer who will handle and optimize the operation of our systems while utilizing the knowledge gained towards future scale up. The ideal candidate will be a team player with strong technical expertise and data analysis capabilities. This role will have an important impact on future company systems.

Key Responsibilities
Operation of multidisciplinary systems- DOEs, testing, data analysis, reports etc.
Provide faster and deeper understanding of the process and system using data analysis tools.
Design and oversee the execution of various engineering projects. Including drawings, project documentation, commissioning and validation tests.
Develop and carry out new testing methods.
Commissioning of new systems all the way towards continuous operation
Troubleshooting, and creative solutions for system related challenges

Basic Job Purpose:
Manage projects related to product line lifecycle from all technical aspects.
Main Duties:
Management of various projects within the Engineering department.
ECO initiation, management and implementation.
Ensure that all projects are delivered on time, within scope and within budget.
Develop a detailed project plan to monitor and track progress.
Report and escalate to management as needed.
Ensure products are manufactured based on the standards set by the organization.
Assist in the definition of project scope and objectives, involving all relevant internal stakeholders and ensuring technical feasibility.
Perform risk management to minimize potential risks.
Track project performance, specifically to analyze the successful completion of short and long-term goals.

* Define system Verification based on system (SW/HW) Design Inputs:
* Study design/reliability requirements.
* Take part in design reviews.
* Define and execute feasibility experiments for proof of concept/design.

* Establish Verification Equipment, Verification Methods and Infrastructure:
* Define, develop, and maintain testing equipment and methods to provide the means to execute verification.
* Collect and analyze data for improvement of methods/processes.

* Plan and execute Design Verification and Process Validation for:
* Developed products and processes.
* Engineering Change Orders.
* Service/Manufacturing equipment and processes.

* Prepare and release Verification Reports:
* Based on collected, analyzed data vs. pre-defined acceptance criteria.
* In compliance with companys QMS and applicable standards/regulations.

* Participate in the following forums:
* Design reviews
* Product development gates and milestones.

* Initiate, manage, and monitor external testing contractors, such as Testing Houses and Labs.
* Define and prepare testing to be performed by external contractors.
* Identify and study relevant standards and guidelines (e.g. transportation/shelf-life standards).
* Track, review and approve external testing reports.
* Working according to Insightec Quality Policy, relevant Quality Procedures & Standards, and privacy & safety rules.

Advantages::

* Experience with MRI/CT/Ultrasound or other imaging modality
* Experience with external contractors
*  Experience in Medical Device industry