Careers

BlueWind is looking for outstanding and talented candidates, to join us on our mission in developing a revolutionary medical device, that will improve dramatically the life quality of many people around the world.

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VP Clinical Affairs- Europe

BlueWind is a Medical device company developing novel wireless Neuro-stimulation device for the treatment of various clinical indications. BlueWind developed a unique platform technology for a leadless, battery-less miniature implant which can be positioned in the vicinity of numerous peripheral nerves. BlueWind has completed a pilot study and is in a stage where a Pivotal, 200 patient, multi-national study has commenced. The design stage has been completed and it is being run in Europe since summer of 2019 and will be expanded to the US in the next few months. The study in Europe includes 12-18 sites of which 6 are open and patient recruitment has begun. We are looking for a strong leader to serve as our VP Clinical Affairs – Europe to successfully implement and execute BlueWind Medical clinical studies in Europe. This position is reporting to the CEO of the company. This is a key position in conducting the pivotal study and further clinical activities with a leading multidisciplinary device that will improve dramatically the quality of life for many people around the world.

RESPONSIBILITIES INCLUDE:

• Managing a team of 5-6 full time employees and several EU-based freelancers and sub-contractors

• Closely Interact with Company’s Medical, Operations and R&D teams to collaborate per each team’s roles and responsibilities

• Lead clinical operations strategic planning activities and translate strategic decisions into actionable operational plans.

• Design standards and processes to optimize all aspects of clinical trials operations and monitor and iterate these processes

• Manage clinical trial budgets

• Manage subcontractors located in Israel and Europe

• Coordinate and manage European EC and competent authorities’ submissions

• Manage enrollment enhancement activities and be accountable for meeting enrollment quotas

• Interact with site personnel as warranted to obtain necessary documentation and information before, during and after the study.

• Prepare and present at investigator meetings

• Oversee the operational selection of various vendors and the review of proposal requests.

• Design and manage all clinical study training: initial training program, Clinical Rep training, training implementation and more.

 

REQUIREMENTS

• Degree in life science/medicine or similar.

• At least 10 years of industry experience in international clinical affairs in medical device companies, 2+ years at a VP level

• Neuroscience experience is preferred but not required

• Deep and broad experience in all aspects of global clinical trial design and execution

• Excellent leadership and interpersonal skills with an ability to effectively work within a multidisciplinary team, provide mentorship to team members and to effectively manage multiple vendors. Ability to efficiently manage direct and indirect reports including remote staff

. • Self-starter who works with a sense of urgency and acts as a good team player working with other disciplines

. • Adaptability, flexibility, independence and resourcefulness to roll-up-sleeves and multi-task in order to thrive in small company environment

. • Ability to proactively identify challenges, possess strategic foresight and implement appropriate courses of action.

• Proven track record of successfully delivering projects on time, to budget and at the required quality

. • Excellent written and verbal communication and presentation skills in English

• Full proficiency with Office software

• Technical orientation

• Ability to travel frequently up to 18 times a year (mostly in EU)

This is a full-time job, located in Herzliya Pituach Please send CV to info@bluewindmedical.com with the name of the position in the title of the email.

Apply now

Senior Software Leader

BlueWind Medical develops a novel wireless battery-less miniature neuro-stimulation device for the treatment of various clinical indications. The device is a unique and complex product, including embedded software of an active neurostimulator Implant, embedded software of a wearable RF transmitter device, and iOS/android-based applications for controlling the whole system. Additional applications are developed for product testing and servicing. We are seeking for a top-notch software leader, who will manage the development of the system software. This is a key position in the development of a leading device that will improve dramatically the quality life of many people around the world. The working environment is dynamic, multidisciplinary and multi-project environment. This position reports to the VP R&D and located in our Israeli office in Herzliya Pituach

RESPONSIBILITIES:
• Leading the development of embedded SW for active neurostimulator implants and their external controllers
• Leading in-house core software development as well as subcontractors
• Leading the development of applications for tablets and  smartphones on different operating systems
• Responsibility for software development through its life cycle
• Preparing and presenting design reviews, writing and maintaining design documentation
• Serving as a source of knowledge for conceptual, functional and technological review of the system architecture through close interaction with the system and hardware engineers
• Software hands-on development for at least 30% of the time

 

REQUIREMENTS:

• Minimum B.Sc. in Computer Engineering, Electrical Engineering or equivalent
• 7 years of hands-on experience in software development for a multidisciplinary product
• 2 years as a Software Leader

• Experience in development of medical device - an advantage
• Experience with Embedded SW for microcontrollers (C, C++)
• Experience with coding Windows and iOS based applications
• Experience in planning software project timelines and resources
• Capable of prioritizing tasks and providing a timely schedule of completion
• Proven experience in leading at least one project with a software sub-contractor
• Capable of providing software requirements, architecture, design and user experience documentation
• Ability to learn and understand new concepts and background information
• Creative and flexible in problem solving
• Excellent communicator
• Fluent in English and Hebrew

Apply now

Senior Mechanical Engineer

BlueWind Medical develops a novel wireless battery-less miniature neuro-stimulation device for the treatment of various clinical indications. The BlueWind system is a unique and complex product, including multiple materials, technologies and processes for both the implantable device and the external control unit. We are working in dynamic, multidisciplinary and multi-project environment. We are seeking for an experienced mechanical engineer to be part of the Mechanical Engineering team and be responsible for leading the transfer to production and production ramp up of the product. This is a key position in bringing to market a leading device that will improve dramatically the quality life of many people around the world. This position reports to the Mechanical Engineering Team Leader

RESPONSIBILITIES:

• Leads the mechanical design and manufacturing process development of an active implantable device and wearable system

• Identifies, works with, and manages sub-contractors, consultants and experts

• Stabilization of high-end manufacturing line including root-cause-analysis, tackling product non-conformities and supporting various quality system processes such as CAPAs, NCRs and ECOs

• Develops and executes V&V and process validations (IQ, OQ, PQ)

• Creates and manages production process documentation including, work instructions, incoming inspections and in-process testing procedures

• Works in conjunction with operations team to develop and implement new manufacturing technologies, manufacturing improvements and scale-up

• Identifies, designs and develops the necessary fixtures and tools for the manufacturing process

• Responsible for production risk assessment and mitigation plans

• Work with product development core team on new products

 

REQUIREMENTS

• Bachelors of Science in Mechanical Engineering (or equivalent experience)

• At least ~ 5 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

This is a full-time job, located in Herzliya Pituach

Please send CV to info@bluewindmedical.com with the name of the position in the title of the email.

Apply now

Process Design and Control Manager

BlueWind Medical develops a novel wireless battery-less miniature neuro-stimulation device for the treatment of various clinical indications. We are seeking a highly professional Process Design and Control Manager to be the engine and driver of continuous improvement processes to ensure organizational excellence. This position is reporting to a VP level and cooperating with all levels of the company We are working in dynamic, multidisciplinary and multi-project environment This is a key position in the development of a leading device that will improve dramatically the quality life of many people around the world.

RESPONSIBILITIES:

• Establish and maintain a company-wide culture of continuous improvement and Operations excellence including Leadership level policy deployment and tiered interactions

• Plan, perform and implement process improvement initiatives

• Diagram and evaluate existing processes and identify missing processes and or inefficiencies

• Review existing process documentation and identify gaps / shortcomings

• Collect data to identify root cause of problems.

• Define and Document end-to-end process flows including external stakeholders and external dependencies

• Develop metrics that provide data for process measurement, identifying indicators for future improvement opportunities.

• Manage projects of tools development for data collection and analysis

• Develop a set of prioritized improvement requirements for processes and tools based upon review results

• Provide support for strategic change efforts to implement agreed process and tool updates

• Measure performance against process requirements.

• Provide support on the use of re-engineering techniques to improve process performance and product quality.

• Liaise with process stakeholders to obtain input and feedback

• Survey and analyze best practices for techniques and processes.

• Communicate to all levels in the organization on improvements and progress

 

REQUIREMENTS:

• BSc. in industrial Engineering or similar

• Proven experience in process review, design, and documentation with recent 3 years of experience

• Medical device industry experience is an advantage

• Capable of analyzing an as-is situation, development of a gap analysis, and definition of a target state

• Excellent project and process management skills

• MS Office and related tool skills are required (PowerPoint, Excel, and process modelling tools in particular)

• Basic programming skills an advantage

• Creative and flexible in problem solving

• Excellent communicator

• Excellent English and Hebrew skills

This is a full-time job, located in Herzliya Pituach Please send CV to info@bluewindmedical.com with the name of the position in the title of the email.

Apply now

Quality Assurance Lead

BlueWind Medical develops a novel wireless battery-less miniature neuro-stimulation device for the treatment of various clinical indications. The BlueWind device is a unique and complex product, including embedded software of a wearable RF-transmitter device, embedded software of an active Implantable medical device, and iOS/android-based applications software for programming and controlling the whole system. We are working in dynamic, multidisciplinary and multi-project environment The QA Lead is responsible for the planning and execution of quality assurance activities ensuring that processes, products and services meet all external and internal quality requirements and are in compliance with regulations. QA Lead supports management and team in all aspects of the Quality Management System (QMS) to: • Facilitate quality minded company culture • Ensure that regulatory, statutory and customer requirements are met for processes and products • Identify and follow up on correction of product nonconformance and process noncompliance situations • Identify and implement opportunities for improvement to product and processes This position interacts with all functions and levels throughout the company and outside the company. Internally, the Quality Manager works closely with R&D and Production to plan, execute, and monitor compliance with QMS. Externally, the Quality Manager interacts frequently with sub-contractors and suppliers when qualifying, auditing and overseeing their work. In addition, the Quality Manager interacts with regulatory agencies that are responsible for auditing the company’s quality system. This is a key position in maintaining and improving the quality system of a company that is developing a leading device that will improve dramatically the quality life of many people around the world. This position reports to the VP QA/RA

RESPONSIBILITIES:

• Assist with development, deployment, and execution of Quality Policies, Quality Objectives, and Quality Plans

• Directly responsible for QMS activities including QA Training, Internal Audits, CAPA Process, Complaints, Change Control, and Document Control

• Responsible for implementation, support, and maintenance of computer systems used for QMS processes

• Support the development and implementation of all QMS processes and procedures across company, including but not limited to; Design and Development, Risk Management, Purchasing & Supplier Quality, Process Control, Identification and Traceability, and Servicing

• Monitor and audit the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement

• Collect, analyze, and present data on the QMS status during Quality and Management Review Meetings

• Representative for audits from external regulatory authorities and registration agencies

• Responsible for supplier qualification and audits

• Responsible for ensuring equipment is calibrated and maintained on schedule

• Determine, implement, and monitor environmental conditions for production and warehouse facilities (including ESD program)

• Reviews DHR and performs Lot release

• Serves as a quality lead in project core teams

 

REQUIREMENTS

• Bachelor’s degree, preferably in an applicable technical discipline

• 5 years of experience in Quality Assurance in medical device development and manufacturing environment, including exposure to FDA/ISO regulations (and standards such as ISO 13485, ISO 14971, 21 CFR 820/211, and MDD/MDR)

• Must have experience in developing, implementing, and maintaining effective Quality System Processes

• Must have specific experience in auditing. Lead auditor/qualification as an internal auditor – an advantage

• Experience in writing procedures, creating management level presentations and reports

• Strong verbal and written communication skills in English

• Must be proficient in the use of Microsoft Office applications • Prior experience with root cause analysis, Statistics, Lean Manufacturing, and Six Sigma – an advantage

• Formal education in Quality – an advantage

• Ability to lead and influence others indirectly

• Assertive – capable of promoting changes

• Organized and methodic

• Detail oriented

• Strong interpersonal skills

This is a full-time job, located in Herzliya Pituach Please send CV to info@bluewindmedical.com with the name of the position in the title of the email.

Apply now

Quality Control Specialist

BlueWind Medical develops a novel wireless battery-less miniature neuro-stimulation device for the treatment of various clinical indications. The BlueWind device is a unique and complex product, including embedded software of a wearable RF-transmitter device, embedded software of an active Implantable medical device, and iOS/android-based applications software for programming and controlling the whole system. We are working in dynamic, multidisciplinary and multi-project environment We are looking for a professional QC Specialist to join the operations team This is an important position in producing a leading device that will improve dramatically the quality life of many people around the world. This position reports to the Operation Lead

RESPONSIBILITIES:

• Inspections (incoming, ATP, final)

• Device assembly

• Equipment maintenance and calibration

• Return parts handling

• Logistics (shipment, purchasing)

• Product release

• Inventory counting

• Logs management (non-conformities, equipment)

• Forms preparation

• Supporting quality department in various tasks

• Assisting other departments on routine basis as the need arises (example: goods received process in Priority)

 

REQUIREMENTS

• At least 3 years of experience in production as QC, preferably in medical device manufacturing

• High level of English, including writing skills

• Knowledge in MS office (word, excel)

• Ability to interface with multiple departments (Operations, Quality, R&D, Finance, Clinical)

• Experience in working in clean room - advantage

• Familiar with Priority - advantage

• Detailed oriented

• Technical skills

• Ability to follow instructions

• Highly organized

This is a full-time job, located in Herzliya Pituach Please send CV to info@bluewindmedical.com with the name of the position in the title of the email.

Apply now

Software QA & Application Engineer

BlueWind Medical develops a novel wireless battery-less miniature neuro-stimulation device for the treatment of various clinical indications. The BlueWind device is a unique and complex product, including embedded software of a wearable RF-transmitter device, embedded software of an active Implantable medical device, and iOS/android-based applications software for programming and controlling the whole system. We are working in dynamic, multidisciplinary and multi-project environment We are seeking for a top-notch engineer to be part of the Software QA & Application team within the R&D group. This is a key position in the development of a leading device that will improve dramatically the quality life of many people around the world. This position reports to the Software QA & Application Team Leader

RESPONSIBILITIES:

The Software QA & Application engineer is expected to take a major role in the verification and validation process of BlueWind software products and to support these products following release. These includes:
• Perform through manual software testing
• Provide feedback to other R&D team members and subcontractors regarding the quality of the software and suggest ways to improve it
• Write and maintain documentation (software requirements, testing protocols, etc.)
• Providing technical support for BlueWind software products during clinical activity

 

REQUIREMENTS

• B.Sc. in Bio-medical engineering or other engineering degree
• 1 year of Hands-on experience in Software QA
• Working experience in medical device companies
• Ability to learn and understand new concepts and background information
• Ability to define user needs and translate it into software requirements
• Capable of planning and prioritizing tasks
• Creative and flexible in problem solving
• Details oriented
• Excellent communicator and team player
• Fluent in English and Hebrew
• Ability to travel abroad
This is a full-time job, located in Herzliya Pituach
Please send CV to info@bluewindmedical.com with the name of the position in the title of the email.

Apply now

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