we are growing and our Principal Mechanical Engineer position is a unique career opportunity that could be your next step towards an exciting future. This role will sit within the Innovalve team, as part of our companys transcatheter mitral and tricuspid therapies (TMTT) product group. Innovalve Bio Medical Ltd. was acquired by our company in July 2024, enhancing the companys transcatheter mitral valve replacement (TMVR) technologies to address large unmet structural heart patient needs and support sustainable long-term growth. This role offers an exciting opportunity to contribute to the development of innovative delivery systems that will revolutionize the treatment of cardiovascular diseases.
How you will make an impact:
As a Principal Engineer, Provides expertise in the optimization of product development for the Innovalve delivery system and accessories.
Manage current development and production efforts of current system running through EFS and IDE clinical studies
Concept Development: Collaborate with cross-functional teams to brainstorm, evaluate, and find innovative design concepts for delivery system components.
Design and Development: Design, analyse, and develop components and processes that meet stringent quality, performance, and regulatory requirements.
Problem-Solving: Identify and troubleshoot complex technical issues that arise during development and clinical trials.
Testing and Validation: Conduct rigorous testing and validation activities, including R&D testing, Design Verification (DV) testing, and clinical trial support.
Engineering Change Orders (ECOs): Initiate and manage ECOs to implement design changes and improvements.
Manufacturing Support: Collaborate with manufacturing engineering to ensure seamless transition of designs into production.
Custom Solutions: Develop tailored solutions for unique design challenges and clinical requirements.
How you will make an impact:
As a Principal Engineer, Provides expertise in the optimization of product development for the Innovalve delivery system and accessories.
Manage current development and production efforts of current system running through EFS and IDE clinical studies
Concept Development: Collaborate with cross-functional teams to brainstorm, evaluate, and find innovative design concepts for delivery system components.
Design and Development: Design, analyse, and develop components and processes that meet stringent quality, performance, and regulatory requirements.
Problem-Solving: Identify and troubleshoot complex technical issues that arise during development and clinical trials.
Testing and Validation: Conduct rigorous testing and validation activities, including R&D testing, Design Verification (DV) testing, and clinical trial support.
Engineering Change Orders (ECOs): Initiate and manage ECOs to implement design changes and improvements.
Manufacturing Support: Collaborate with manufacturing engineering to ensure seamless transition of designs into production.
Custom Solutions: Develop tailored solutions for unique design challenges and clinical requirements.
Requirements:
B.Sc. in Mechanical engineering
Minimum of 4 years of experience in medical device design and development.
Strong understanding of mechanical engineering principles, including materials science, stress analysis, and manufacturing processes.
Analytical, problem-solving, and critical thinking skills.
High verbal communication skills.
Ability to make decisions under pressure.
Great attention to detail and organizational skills.
Proficiency in English and Hebrew
Proficiency in CAD software (SolidWorks, Creo, or similar).
Experience with regulatory requirements (e.g., ISO 13485, FDA QSR).
Ability to work independently and as part of a cross-functional team.
B.Sc. in Mechanical engineering
Minimum of 4 years of experience in medical device design and development.
Strong understanding of mechanical engineering principles, including materials science, stress analysis, and manufacturing processes.
Analytical, problem-solving, and critical thinking skills.
High verbal communication skills.
Ability to make decisions under pressure.
Great attention to detail and organizational skills.
Proficiency in English and Hebrew
Proficiency in CAD software (SolidWorks, Creo, or similar).
Experience with regulatory requirements (e.g., ISO 13485, FDA QSR).
Ability to work independently and as part of a cross-functional team.
This position is open to all candidates.
