Project Manager – Automation | Yoqneam
Radix Engineering, specialists in engineering services for the transition from development to manufacturing, is recruiting for one of our clients—a leading Medical Device company located in Yoqneam. We are looking for an experienced Project Manager to lead end-to-end automation projects for catheter assembly, combining project management and system engineering expertise to deliver scalable, high-precision manufacturing systems. This is a high-impact role requiring strong system thinking, multidisciplinary integration capabilities, and proven experience managing complex engineering projects from concept through production transfer. Key Responsibilities:• Lead the full project lifecycle: concept → design → build → validation → production transfer.• Define system architecture, including mechanical, control, vision, and process aspects.• Manage project timelines, budgets, risks, and key performance indicators (KPIs).• Lead cross-functional teams including R&D, engineering, manufacturing, and operations.• Manage external integrators and suppliers.• Ensure compliance with quality, validation, and regulatory requirements. Requirements:• B.Sc. in Mechanical Engineering, Biomedical Engineering, or System Engineering – Mandatory.• 5–10+ years of experience in automation, medical devices, or advanced manufacturing environments – Mandatory.• Proven experience managing complex engineering projects from concept to production.• Strong system-level thinking and ability to integrate multidisciplinary systems.• Experience with automation systems, manufacturing processes, and production transfer.• Excellent project management, communication, and leadership skills.• Experience with validation processes (FAT/SAT) and risk analysis (FMEA) – Advantage. Location: Yoqneam, Israel To apply, please send your CV to:[email protected]
Senior Mechanical Engineer | Yoqneam
Radix Engineering, specialists in engineering services for the transition from development to manufacturing, is recruiting for one of our clients—a leading Medical Device company located in Yoqneam. We are looking for an experienced Senior Mechanical Engineer to join an innovative R&D team developing next-generation automated manufacturing technologies. This is a hands-on, high-impact engineering position within a multidisciplinary team (non-managerial), focused on designing advanced automation systems for medical device manufacturing. Key Responsibilities:• Lead the mechanical design and development of automated manufacturing systems.• Manage projects from concept and feasibility through prototyping, testing, and transfer to production.• Design complex mechanical and electromechanical systems while considering system-level requirements.• Perform engineering analyses, simulations, and experimental prototyping.• Collaborate closely with Hardware, Software, Vision, Algorithms, Robotics, and Manufacturing teams.• Evaluate and integrate new technologies into future manufacturing solutions. Requirements:• B.Sc., M.Sc., or Ph.D. in Mechanical Engineering – Mandatory.• At least 7 years of hands-on experience in mechanical design and development of complex mechanical systems – Mandatory.• Proven experience designing automation systems and working in multidisciplinary environments involving automation, robotics, and electromechanical systems – Mandatory.• Strong knowledge of mechanical design principles, dynamics, materials, and electromechanical systems.• Proficiency in SolidWorks or similar CAD software.• Experience with engineering simulations – Advantage.• Experience with micro-mechanisms – Advantage.• Excellent technical documentation and technical writing skills.• Fluent in Hebrew and English.• Innovative mindset, strong system-level thinking, excellent problem-solving skills, and outstanding communication abilities. Location: Yoqneam, Israel To apply, please send your CV to:[email protected]
Laboratory Technician – Radix Engineering (On-site)
Location: Yoqneam Illit A leading medical device company is seeking a Laboratory Technician for a hands-on role involving advanced electronic systems, supporting R&D and transfer to production. Responsibilities:Assembly, integration, and calibration of electronic systems and boardsDebugging and troubleshooting electronic boards and systemsPerforming functional testing using lab equipment (oscilloscope, multimeter, power supplies, waveform generators, etc.)Reading and analyzing electrical schematics (OrCAD, PCB Viewer, PSpice)Working with schematics and understanding PCB development and manufacturing processesSupporting bring-up and system integration activitiesWriting and maintaining technical documentation: test procedures, change orders, and data documentation in information systemsWorking closely with R&D and engineering teams during NPI (transfer to production) processes Requirements:Practical Engineer (Electronics) or relevant experienceHands-on experience with electronic boards and debuggingExperience working with electronic test equipmentAbility to read and understand electrical schematicsFamiliarity with PCB development and manufacturing processesExperience in transfer from R&D to production – advantageFamiliarity with programming languages (C, VHDL, Assembly) and tools such as Quartus / Vivado – AdvantageExperience in writing technical documentation CV: [email protected]
Regulatory Affairs Specialist
Regulatory Affairs SpecialistGlobal Medical Device Company – YokneamHybrid: 3 days onsite, 2 days from home We are seeking a Regulatory Affairs Specialist to join a leading global medical device company. This role includes ownership of regulatory submissions, technical documentation, and change management within multidisciplinary systems involving hardware, software, and invasive medical technologies. What You’ll Do* Lead end-to-end regulatory submissions, including technical documentation, change submissions, and authoring regulatory files for global markets.* Manage regulatory aspects of design and manufacturing changes, including impact assessments on global approvals.* Develop regulatory strategies for the US and EU markets.* Collaborate directly with regulatory authorities, including regular interactions with US (FDA) and European agencies.* Work closely with internal cross-functional teams-R&D, Operations, Quality, Engineering-as well as external partners.* Participate in discussions with development and operations teams regarding new products and ongoing changes.* Occasionally participate in evening calls with US-based teams.* Work in a hybrid model: 3 days in the Yokneam office, 2 days from home. Requirements* Minimum 4 years of experience in Regulatory Affairs in the medical device industry (not pharma).* Experience with multidisciplinary systems (hardware, software, invasive devices).* Strong independent work style, fast execution, and assertiveness.* Excellent command of English—both written and spoken.* Proven experience in authoring technical regulatory documents and leading submissions.* Motivation to grow and remain in the role for several years.
Regulatory Affairs Program Lead
Regulatory Affairs Program Lead📍 Yokneam Illit, Israel | Hybrid Radix Engineering is recruiting on behalf of a leading global medical device company. We are seeking a highly talented and strategic Regulatory Affairs Program Lead to drive global regulatory programs and lead complex regulatory pathways from product development through worldwide market approvals. This is an excellent opportunity for an experienced Regulatory Affairs professional looking to make a significant impact within a dynamic and innovative organization. Key Responsibilities • Develop, execute, and manage comprehensive regulatory strategies and pathways for innovative and modified medical devices.• Lead the preparation and submission of complex FDA and international regulatory filings to support timely global market approvals.• Ensure product development activities and clinical studies align with applicable regulatory requirements and business objectives.• Serve as the primary regulatory interface with global regulatory authorities, including FDA, DEKRA, NMPA, and PMDA, as well as regional affiliates worldwide.• Collaborate closely with cross-functional teams, including R&D, Clinical, Quality, and other key stakeholders, to support successful product development and commercialization. Requirements • Bachelor’s degree or higher in a relevant scientific or engineering discipline.• 6–8 years of Regulatory Affairs experience within the medical device industry (pharmaceutical experience is not applicable).• Proven expertise in managing complex regulatory pathways and international regulatory submissions.• Strong leadership skills, strategic thinking, and excellent communication abilities.• Willingness and ability to travel internationally up to 10% of the time.
Senior Regulatory Affairs Specialist – Clinical Submissions
Global Medical Device Company – YokneamHybrid: 3 days onsite | 2 days remote We are seeking a Senior Regulatory Affairs Specialist with a strong focus on regulatory submissions to join a leading global medical device company. This role will lead regulatory activities supporting clinical investigations, including IDE, IRB/EC submissions, and collaborative clinical studies, for complex multidisciplinary medical devices (hardware, software, invasive technologies). What You’ll DoLead and manage clinical regulatory submissions, including IDE submissions, IRB/EC applications, amendments, and ongoing study maintenance.Serve as the regulatory lead for US and EU clinical investigation activities, supporting first‑in‑human, feasibility, and pivotal studies.Prepare, review, and maintain clinical regulatory documentation, including protocols, Investigator’s Brochures, clinical risk sections, and regulatory responses.Support regulatory strategy development for clinical programs, ensuring alignment with development, clinical, and business objectives.Act as a primary regulatory interface with FDA and European regulatory bodies related to clinical studies.Collaborate closely with Clinical, R&D, Quality, Biostatistics, Operations, and external clinical partners/CROs.Participate in cross‑functional discussions supporting new product development and clinical evidence generation.Occasionally participate in evening calls with US‑based teams.Work in a hybrid model: 3 days in the Yokneam office, 2 days from home. RequirementsMinimum 4 years of experience in Regulatory Affairs within the medical device industry (not pharma).Hands‑on experience with clinical submissions (e.g., IDE, IRB/EC) is strongly preferred.Experience with multidisciplinary medical devices (hardware, software, invasive systems).Strong understanding of US and EU clinical regulatory frameworks.Proven ability to independently author and lead complex regulatory submissions.Assertive, proactive, and capable of working independently in a fast‑paced environment.Excellent command of English, written and spoken.Motivation to grow and remain in the role for several years.
Engineering & Configuration Management Leader | Electronics & EMS – Petah Tikva
Location: Petah Tikva Radix Engineering is looking for a professional Engineering & Configuration Management Leader to join a significant technological project at a leading Electronics Manufacturing Services (EMS) client. The role serves as the primary engineering authority bridging the gap between R&D and production, with full responsibility for the product’s engineering file and NPI processes. Key Responsibilities: Requirements:
Mechanical Engineer for the Defense Industry – Petah Tikva area
Mechanical Engineer Defense Industry – Petah Tikva area A defense company in the Petah Tikva area is seeking a Mechanical Engineer. Job Description: Responsible for full mechanical design, including detailed drawings and design-for-manufacturing (DFM) of complex components and systems, including load and strength calculations. The role includes supporting the Transfer to Production (NPI) process, working with R&D and manufacturing teams, and coordinating across multidisciplinary fields (Electrical, Software, and Manufacturing Engineering). Key Responsibilities: Requirements:
Quality Inspector (QA/QC) – Part-Time
Location: Petah Tikva (includes travel to suppliers) | Sector: Aerospace / Defense | Position Type: Part-time Job Description: Performing professional quality inspections within the aerospace manufacturing field, working with wiring systems and electrical harnesses. The role involves working according to strict quality standards (AS/ISO) and overseeing production processes from the assembly stage to final testing, including ongoing collaboration with suppliers. Responsibilities: Requirements: Significant Advantages:
QA Specialist | Medical Device
Location: Caesarea A leading Medical Device company is looking for a QA Specialist for a significant role within the Quality department. The position involves ongoing work with the Quality Management System (QMS) and supporting production and R&D processes. Responsibilities: Requirements: