careers

The quality and regulatory compliance specialist is responsible for implementing and executing repeatable and sustainable regulatory and quality processes to ensure on-going compliance with domestic and international regulations and standards. He is also a crucial team member responsible for managing the CAPA and Complaint processes, coordinating investigations, review, follow-up, closure, and trend analysis on Compliant data.

• Review customer feedback, service records, and other sources of customer and internal feedback for possible complaint.
• Manage the Complaint handling process end-to-end while working collaboratively with cross-functional teams to complete risk assessment, investigation and resolution of the complaints. Determine the need and report to regulatory authorities as needed.
• Manage the CAPA process end-to-end while working collaboratively with cross-functional teams to complete risk assessment, investigation, corrective and preventive action and effectiveness evaluation.
• Coordinate and participate in Internal and External Audits
• Support post-market regulatory activities and submission of reports to regulatory authorities.
• Proactively identify issues and potential trends requiring investigation by internal resources
• Periodically review quality objectives with team members
• Develop and post monthly metrics, KPI’s and dashboards.

• Bachelor’s Degree in Engineering, Science or technical field
• 2-5 years of Regulatory Affairs or Quality Assurance experience in Medical device companies
• Knowledge of global medical device standards and regulations such as ISO 13485, EU MDD/MDR and FDA 21 CFR
• Ability to work effectively independently and in a team environment with a diverse group of people
• Fluent in English and Hebrew
• Self-motivated; works independently with minimal supervision.
• Takes initiative to establish and meet goals and objectives.
• Ability to speak with clarity and express points of view in a variety of settings; one-on-one interactions, group meetings, and formal presentations
• Exhibit flexibility and adaptability by managing assignments in accordance with project priorities and by altering course of action when and where necessary.
• Strong analytical, problem solving, organizational, and planning skills.
• Demonstrated good documentation practices

• Overall responsibility for operation Quality System management.
• Support day to day manufacturing activities
• Leading manufacturing transfer quality engineering activities including process validation and pFMEA.
• Responsible for managing the Approved Supplier List (ASL)
• Performing data analysis and reporting for Supplier Quality Performance Monitoring, assisting in the development of Quality processes relating to Supplier Quality Control’s.
• Leading product quality investigations in support of CAPA, complaints and Non-conforming material processes.
• Provides feedback, reviews, and approves Engineering Changes.
• Leading Quality Assurance and product quality improvements cross functional initiatives
• Bachelor’s Degree in Engineering, Science or technical field
• 3+ Years of Quality Assurance experience in Medical device companies
• Knowledge of global medical device standards and regulations such as ISO 13485, EU MDD/MDR, FDA 21 CFR and ISO 14971
• Experience in sterile medical devices – an advantage
• Vast experience with design changes, change impact assessment and design transfer activities.
• Ability to work effectively independently and in a team environment with a diverse group of people
• Fluent in English and Hebrew

We are seeking an experienced cross functional Project Manager to be part of our PMO. This is a key position in bringing to market a miniature robotic system to change the world of robotic assisted surgery.

The candidate will be responsible for managing key strategic projects - from project Initiation to launch, including project planning, risk assessment, resource management, and timely communication of key milestones and deliverables. The projects may range from product development for commercial launches, for clinical studies or advanced technology feasibility initiatives.

The candidate should have had multiple cycles of success running complex projects through a complete product life cycle in the medical device industry. He/She should be able to work successfully in a fast-paced environment including multiple platforms, architectures and global teams. The individual will work closely with R&D, engineering, marketing, product managers, clinical, regulatory, quality, supply chain and other cross functional members as required.

• Define project needs and lead the project through its product development cycle from project charter to launch.
• Develop detailed project plan that is both holistic and detailed and takes into account both design control deliverables and other deliverables required for a clinical study or commercial launch.
• Proactively manage changes to the project scope, schedule and costs.
• Coordinate internal and third parties/vendors resources for the project different tasks.
• Ensure resource availability and allocation.
• Be adept at working with external partners located globally and integrating them into the team.
• Responsibility for the design control process of the project and deliverables associated with project phase/stage gates.
• Responsibility for communicating project status within project team and management.
• Work in conjunction with the Engineering team to support manufacturing scale-up, incorporate new design changes, and make manufacturing improvements.

• • Bachelor degree in Mechanical / Biomedical Engineering / Industrial (or equivalent experience).
  • 2-4 years of experience managing projects in the medical device industry that includes multi-disciplinary systems.
  • Deep expertise of product development best practice and process, having both big picture awareness and hands-on knowledge.
  • Project management for class II medical devices is a plus
  • Strong communications skills in both English and Hebrew.
  • Deep technological understanding and creativity in hands-on problem solving
  • Strong writing capabilities in Hebrew and English
  • Self-starter, self-learner, and self-organizer

Overall responsibility for regulatory submissions of new products to regulatory agencies (US, EU and ROW) and regulatory compliance for existing products. This includes supporting all design control activities, developing regulatory strategy, providing regulatory requirements, supporting the development activities, preparing and submitting new product applications to regulatory agencies and responding to additional information requests.

• Develop regulatory strategy for submissions of new products and changes to existing products
• Support, prepare and coordinate regulatory submissions of new products or changes to existing products.
• Prepare and maintain technical files and general safety and performance requirements
• Coordinate and communicate activities with external consultants and regulatory bodies
• Review DHF documentation to assure compliance with regulatory requirements.
• Review and interpret regulatory requirements during product development and communicate to the project team
• Review of V&V protocols and reports to assure comprehensiveness, accuracy and clarity for regulatory submissions
• Support Risk Management activities
• Create, update and maintain standards list
• Support manufacturing activities related to the product
• Provide requirements for, review and approve product labelling
• Support compliant handling
• Report to regulatory authorities

We are looking for motivated and talented assistant controller to join our team

• Support month-end closing processes.
• Working with bookkeeping functions.
• Reconciliation AP/AR/Inventory/FA and etc.
• Preparation of the consolidated financial statements.
• Assisting in internal control implementation (SOX)
• Working with external auditors.
• IIA reports

• Certified public accountant
• 2-3 years of experience (including internship) from big 4 accounting firm, Hitech department.
• Experience and knowledge in U.S GAAP standards.
• Hands-on, excellent interpersonal skills, a team player.
• Multitasking
• Ability to work in a fast-paced work environment.
• Accurate and detailed oriented with a high level of analytical and professional skills.

Memic is looking for Quality Control to join our team.

The Quality Control ensures that the company's products are in compliance with their specifications, the company's policies and international standards and guidance.

• Perform variety of inspection activities including visual, dimensional, mechanical and functional inspections
• Follow established procedures to ensure compliance with procedures, visual aids, purchased specifications, inspection forms, work orders or engineering drawings;
• Perform first article inspections on incoming product;
• Initiate nonconforming material reports for product or raw material found to be out of specification. Assisting with investigation and rework;
• Ensure compliance of quality records and supporting documents with internal procedures and GDP practices
• Review Device History Records and approve products for distribution;
• Provides support for technical and quality issues
• Maintain production equipment
• Participate in internal and external audits

• At least 2 years of experience as Quality Control in the Medical Device Industry
• Prior work experience in a regulated manufacturing environment (ISO 13485, 21 CFR Part 820)
• Basic knowledge and understanding of metrology
• Experience in using mechanical and electronic test equipment (i.e: caliper, snap gauge, pin gauge, DVM, micrometer, etc)
• Ability to read and interpret documentation such as Standard Operating Procedures (SOP), schematics and technical drawings
• Basic computer skills, including basic use of Microsoft Office suite software and NetSuite, or equivalent software
• Good English and Hebrew skills

We are looking for a skilled Verification and Validation Engineer to design and implement test procedures for our robotic systems.

Gain in-depth knowledge in system requirements, system architecture, and features and work with all R&D disciplines.

• Create verification protocols and reports • Perform basic statistical analysis on collected data and present results • Coverage and traceability of tests to product requirements • Executing test cases in accordance with system test plans to ensure product compliance with applicable standards. • Perform gap analysis on different modules of the product • being involved in the full product lifecycle including design, testing, documentation and ECOs implementation. • manage 3rd party testing and validation activities • Participate in ECO and MRB processes.

• Bachelor’s Degree in an engineering discipline • At least 3 years of experience in the Medical device industry (multidisciplinary products - advantage) • Experience in R&D and verification teams • Familiarity with Sterilization validation, biocompatibility testing – Advantage • Knowledge of testing methodologies • Experience in testing according to medical standards - an advantage • Multitasker, responsible, hands-on approach • Ability to work within tight deadlines • High communication skills (written and interpersonal) • Fluent English • The position is full-time.

responsible for purchasing, delivery schedule, supplier performance and relationship management of suppliers who deliver components for the manufacturing and R&D.

• Timely creation and distribution of raw materials, components, equipment, tooling, supplies and services Purchase Orders to support NPI and manufacturing activities
• Confirm delivery dates and expedite
• Development and Implementation of cost-saving initiatives
• Ensure that good relations are created and maintained between Memic and suppliers
• Complete Purchasing tasks in accordance with SOP standards
• Participate in MRB session for non-conforming materials and activate timely return of non-conforming materials to vendor
• Prepare monthly metrics for Supplier Scorecards

• Practical engineer or Bachelor's Degree in Mechanical Engineering or other relevant discipline with a focus on purchasing
• 2-3 years’ experience in a purchasing and or planning role within a manufacturing environment (experience in medical device company - advantage)
• Strong knowledge of manufacturing ERP/MRP Systems (Priority - advantage)
• Good computer skills –
  • MS Office SW (Word, Excel, PowerPoint)
  • PLM system
• Good organizational and time management skills
• English communication skills (verbal and written)
• Valid driving license

The Electrical Project  Engineer is responsible for the Electrical Engineering; all Electrical Drawings, Electrical boards documentations and failures analysis,  Electronics related ECOs leading, Production Engineering projects leading, and for Production Files creation and corrections.

The Engineer will be involved with all aspects of the Engineering department and will support the product and system engineers as required.

• Every possible task to support the engineering department to stabilize the production files and production processes.
•  Small projects leading
• Failures investigation
• Production processes improvement
• Production files creation and corrections
• Engineering Change Orders tasks (carryout and follow-ups)
•  Assembly instructions write and review  
• Electrical BOMs ownership
• Harnesses and electrical wiring schemes.

• Electrical/Practical engineer/Biomedical Engineer (or 4^thyear engineering student)
• Up to 4 years of experience.
• Experience with electrical boards and harnesses production files
• VERY High ambition and willingness to learn
• Desire to join a fast-moving company, and work hard!
• Well organized and accurate.
• Fast learning
• Excellent teamwork abilities
• Good English

The Product Manager will be responsible for managing the entire product lifecycle of a new general surgery application for the Memic robotic system and associated instruments and accessories. This includes gathering and prioritizing product and customer requirements, defining the product roadmap, and working closely with clinical development engineering and new product development to deliver the product to the marketplace. The Product Manager will also identify and drive post-launch product improvements and provide sustaining support for product field issues. The role includes providing direct product-level support to the sales team and physicians to ensure successful adoption.

• 7+ years total marketing experience in surgical medical devices, with at least 3 years in general surgery.
• Strong oral and written communication skills.
• Excellent organizational and project management skills.
• Strong facilitation skills.
• Demonstrated experience in developing presentation materials for sales force.
• Proven ability to determine and communicate effective product positioning and key marketing strategies.
• Demonstrated ability to plan, organize, manage and execute on several marketing projects simultaneously, within budget.
• Experience in financial modeling and performance metrics of marketing campaigns including researching, analyzing, and quantifying of portfolio products and competitive products.
• Relationships with thought leaders and KOLs.
• Experience launching a medical device product to the medical community and knowledge of regulatory issues
• Proven ability to handle complex negotiations and experience with senior level managers and customers.
• Strong analytic marketing knowledge and experience.
• Ability to demonstrate integrity, adaptability, self-initiation and strong work ethic
• Ability to travel up to 40% of time.
• Bachelor’s degree required, MBA preferred.

We are seeking an experienced mechanical engineer to be part of our R&D team. The qualified candidate will be responsible for improving the mechanical design, performance, and reliability of our unique articulated surgical instruments.

This is a key position in bringing to market a miniature robotic system to change the world of robotic assisted surgery.

• Take Responsibility for design and development projects aiming at improving device reliability and performance.
• Identify opportunities for design improvements in a complex mechanical system.
• Perform hands-on mechanical design of a robotic surgical instrument.
• Manage design projects involving sub-contractors designers and manufacturers.
• Work in conjunction with the Engineering team to support manufacturing scale-up, incorporate new design changes, and make manufacturing improvements.

• Bachelors of Science in Mechanical Engineering (or equivalent experience)
• At least ~2 years of hands-on professional experience in a similar position in a medical device company or military sector
• Background in design and development, including design with Solid Works
• Deep technological understanding and creativity in hands-on problem solving
• Strong writing capabilities in Hebrew and English
• Self-starter, self-learner, and self-organizer
• Possess a keen attention to detail
• Excellent communicator and team player
• Working experience in medical devices - Advantage
• Working experience on a multi-disciplinary system. - Advantage

The Engineering Project Manager (EPM) is responsible for external and internal, post R&D / released products, related projects.

The EPM and his team will constantly conduct and manage improvement projects for Manufacturability, Reliability, Performances improvement, Cost reduction and any other topic which will enhance/improve Memic’s products.

The EPM will have deep understanding of Memic’s products, side by side with deep understanding of as many as possible manufacturing technologies.

A day in the EPM life, will be full with multidisciplinary systems understanding, problems solving, external subcontractor management, team leading, etc.

The EPM will have tight (and very good!) links with the R&D, NPI, Product Engineering, System and other teams.

• Engineering Projects leading (internal and external)
• Production lines establishment
• Production process automation
• FTK suppliers management
• Failures investigations
• Performances improvement
• Cost reduction projects
• NPI processes.

• Mechanical/Biomedical Engineer
• More than 5 years of experience.
• Understanding of small and accurate metal parts machining technologies
• Understanding of laser cutting and welding
• Fluent with SolidWorks – Parts (sheet-metal, surfaces, etc.), Assemblies, Drawings, Configurations.
• VERY High ambition and willingness to learn
• Desire to join a fast moving company, and work hard!
• Well organized and accurate.
• Team management abilities
• Fast learning abilities
• Excellent team work abilities
• Very good English