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NPI Engineer

Healium Medical is an early-stage medical device company developing transcatheter ultrasound therapeutic technology for the treatment of cardiac arrhythmias. The company’s technology is multidisciplinary and consists of micro-mechanics, micro-electronics, hardware, software, and signal and image algorithm processing. The company is backed by strategic investors, has development collaborations projects with strategic partners, won 1st place at the prestigious ICI2019 Technological Innovation Competition, and was recently awarded the European Innovation Council (EIC) 2021 grant. and selected for the Medtech Innovator - the largest and highest performing accelerator of medical technology in the world.

We are seeking a New Product Introduction and Process Engineer to join the Mechanical team in the company. To succeed and fit in, you’d need great interpersonal skills, be a team player, a thinker, a self-learner, hands-on engineer, highly diligent & motivated, and scrutiny alongside a strong passion for ensuring the best quality of medical devices


To succeed you must have a strong hands-on attitude, be very organized with natural curiosity to learn of new materials, suppliers, technologies and solution. To fit in the company, you must have great interpersonal skills, be a team player, completely independent, a thinker, a self-learner, motivated, have a broad system perspective of the entire technological solution, alongside a strong passion for medical devices development.


YOUR RESPONSIBILITIES

§ Establish, maintain, and improve the production lines of Healium’s catheters while collaborating with manufacturing subcontractors

§ Define and deploy cleanroom procedures.

§ Maintain the production inventory including purchasing raw materials and subassemblies; create production kits

§ Define requirements for manufacturing fixtures, their validation, and deployment in production work instructions

§ Define production line tools and maintain their calibration

§ Lead design transfer activities including PFMEA, Production Process validation & technician training program

§ Collaborate with R&D teams (Catheter developers, System, HW), and product managers to become intimately familiar with product design and functionality

§ Participate in design reviews to ensure Design for Manufacturability (DFM)

§ Collaborate with Quality Team to establish robust QC checkpoints for procurement and production line

§ Capture all nonconformities with all data required for reproducing the issues and participate in investigations and related CAPAs



YOUR EDUCATION & WORK EXPERIENCE

§Engineering Degree in mechanical, biomedical, material science (or equivalent)

§Proven experience of at least 2 years in production process engineering / new product introduction, preferably for medical devices

§ High level of verbal and written English


ADVANTAGES

§Experience working in cleanroom environment

§Experience in procurement and creating and managing inventory

§Experience in managing production subcontractors

§Experience in developing production fixtures and conducting test method validation

§ Familiar with PDM system


WHY SHOULD YOU JOIN

Join an early-stage startup competing in a billion-dollar industry and touch millions of lives by developing a unique ultrasound-based medical device solution. If you are passionate about interventional medical device technology this is your place. You will be a major function in our team leading our transcatheter ultrasound technology while being involved in all mechanical aspects of the system. This role offers the unique opportunity to be an entrepreneur in an early-stage start-up and enjoy the capability to influence & lead while enjoying the company’s future growth.


SOUNDS INTERESTING? YOU BET!

Please send your CV and a short description to assaf

SOUNDS INTERESTING? YOU BET!

Please send your CV and a short description to rans@healiumedical.com 

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