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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 transcatheter mitral and tricuspid therapies (TMTT) product group. Innovalve Bio Medical Ltd. was acquired 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

Required Sustain Mechanical Engineer
- Full technical ownership of assigned product lines across their lifecycle, serving as the senior engineering authority for sustaining activities
- Lead mechanical design changes in multidisciplinary products to improve quality, reliability, manufacturability, serviceability, and customer experience
- Drive cost-reduction initiatives (VAVE / Cost Down) through redesign of mechanical and electromechanical assemblies, materials, and manufacturing processes
- Lead root cause analysis (RCA) and implement corrective and preventive actions (CAPA) for field failures and production issues
- Provide ongoing engineering support to manufacturing and suppliers, including design optimization, tooling development, and first article inspections (FAI).

Skincare technology expert Pollogen is a dynamic subsidiary of our company, a global pioneer in energy-based technology for the aesthetics and vision domains with sales in nearly 100 countries, a large and growing installed-base, and strong presence in the US, Europe, and Asia. Pollogen offers a fresh approach to innovation, specializing in professional-grade and home-use devices that provide real results. Combined with our companys six decades of market leadership, 330+ patents, 500+ clinical publications, Pollogen and our company offer the perfect balance of scientific artistry and creative excellence.
Basic Job Purpose
The Project Manager is accountable for end-to-end delivery of multidisciplinary medical device development projects, ensuring alignment between business needs, technical execution, regulatory compliance, and product lifecycle objectives.
Key Responsibilities
Full ownership of product development projects from initiation through market release and lifecycle management
Planning and execution of project scope, budget, resources, milestones, and schedules
Close collaboration with Product, Business Development, and Marketing to translate market and customer needs into technical deliverables
Leadership of multidisciplinary teams, including R&D, software, regulatory, clinical, operations, and external subcontractors
Definition and control of system-level requirements, including hardware, software, and integration aspects
Continuous monitoring of execution, risks, dependencies, and mitigation plans, with proactive decision-making
Enforcement of medical device development processes, quality systems, and regulatory standards across all disciplines
Ownership of development documentation, including DHF, DMR, and software lifecycle documentation
Accountability for verification and validation activities at system, hardware, and software levels
Leadership of transition to manufacturing, including test strategies, production readiness, and change control
Support of regulatory submissions, safety testing, root cause analysis, and implementation of corrective actions.

Power the Future with us! At our company, we're a global leader in smart energy technology, with over 4,000 employees, offices in 34 countries, and millions of installations worldwide. Our innovative solutions include solar inverters, battery Storage, backup systems, EV charging, and AI-based energy management. We're committed to making clean, green energy the primary power source for homes, businesses, and beyond. With the growing demand for electricity, the need for smart, clean energy sources is constantly rising. our company offers amazing opportunities to develop your skills in a multidisciplinary environment, covering everything from research and development to production and customer supply. Work with talented colleagues, tackle exciting challenges, and help create a sustainable future in an industry that's always evolving and innovating. Join us and be part of a company that values creativity, agility, and impactful work. What you will be doing:
* Support production lines and manage field issues
* Investigate production failures and suggest solutions
* Define and approve mechanical components and fasteners
* Review first article inspections reports (FAI) and approve parts for mass production
Country:
Israel
City:
Herzliya