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.

It's time to make a difference - apply today!

Quality Assurance Lead/Manager

The QA lead/manager is responsible for all aspects of the Quality Management System (QMS), facilitating quality minded company culture and ensuring processes, products and services meet all external and internal quality requirements and are in compliance with regulations. The QA lead/manager interacts with all functions and levels throughout the company and outside the company working in an international, multidisciplinary and multi-project environment. The position reports to the VP QA/RA located in the US and requires on-going communications with a large team, based in the US, Europe and Israel.

RESPONSIBILITIES:

• Directly responsible for QMS activities including CAPA Process, Complaints, Manufacturing Deviation (NCRs), Change Control, Document Control, Internal Audits, Supplier Qualification and QA Training

• 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

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

• Responsible for supplier qualification and audits

REQUIREMENTS:

• Bachelor’s degree a must, formal education in Quality – an advantage

• At least 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 experience in leading or participating in audits

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

• Prior experience with international companies - an advantage

• Assertiveness – capable of promoting changes

• Detail oriented, organized and methodical

• Strong interpersonal skills and ability to work in multi-disciplinary teams and influence others indirectly

• Strong verbal and written communication skills in English - mother tongue level

• Lead auditor/qualification as an internal auditor – an advantage

• Prior hands-on experience with QA for manufacturing – an advantage

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

NPI and Quality Engineer

The NPI and Quality Engineer leads the engineering and quality aspects in all product development and manufacturing processes. Facilitates quality minded company culture and ensures processes, products and services meet all external and internal quality requirements and are in compliance with regulations. The NPI and Quality Engineer interacts with all functions and levels throughout the company and outside the company working in an international, multidisciplinary and multi-project environment. The position reports to the VP QA/RA located in the US and requires on-going communications with a large team, based in the US, Europe and Israel.

RESPONSIBILITIES:

• Leads ECR/ECOs including responsibility for DMR, BOM and configuration management
• Approves of all mechanical/electrical drawings, production specifications and work instructions
• Leads Material Review Board (MRB), defines disposition of Non-Conforming Materials (NCMRs) as appropriate
• Leads root cause analyses (RCAs) and responds with corrective actions
• Leads/supports process and test method validation activities (OQ, PQ, TMV)
• Review DHR and perform Lot release
• Prepares, supervises and reports suitable and effectual production metrics monitoring
• Oversees inspection activities and supervises quality documents
• Determines, implements, and monitors environmental conditions for production and warehouse facilities
• Responsible for ensuring equipment is calibrated and maintained on schedule

REQUIREMENTS:

• Engineering degree, preferably in an applicable technical discipline, formal education in Quality – an advantage
• 3 years of experience in NPI/Configuration Management/Quality Engineering in medical devices
• Experience in leading Root Cause Analysis (RCA) and statistical analysis.
• Six Sigma Green or Black Belt – an advantage
• Experience with Process Validations (IQ/OQ/PQ) and Test Methods Validations (TMV)
• Detail oriented, organized and methodical with hands-on approach
• Prior experience with international companies - an advantage
• Strong interpersonal skills and ability to work in multi-disciplinary teams and influence others indirectly
• Strong verbal and written communication skills in English

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

Practical Electronics Engineer

The Practical Electronics Engineer will be a part of the hardware development team. He/she will be involved in various activities of development and technical support, focusing on product testing and investigation. The role requires hands-on capabilities, familiarity with lab equipment, proven ability to dive into details and work independently. The position reports to the HW Leader.

RESPONSIBILITIES:

• Performing hardware investigations following customer complaints and manufacturing failures
• Performing tests as part of product development process
• Other functions as allocated by the HW leader

REQUIREMENTS:

• Practical Electronics Engineering graduate
• 3-5 years of experience in high-tech or medical devices industry
• Hands-on capabilities, familiarity with operation of lab equipment, experienced with soldering
• Experience in writing tests protocols, performing tests and writing report results (in English)
• Familiar with board design (Analog, Digital, Power) - an advantage
• Detailed oriented, organized and methodical, able to work independently
• Capable of prioritizing tasks and providing a timely schedule for completion
• Team player
• Strong verbal and written communication skills in English

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 System Engineer

The System Engineer is responsible for overall system architecture and design, system technical requirements, compliance with standards and regulatory guidelines, risk and hazard management, traceability, system verification and validation and system level failures problem solving. The role reports to the VP R&D.

RESPONSIBILITIES:

• Leads system and sub-system architecture, performance metrics, technical aspects of product manufacturing and service

• Defines system and sub-systems technical requirements and interfaces

• Leads and participates in risk and hazard analysis activities

• Identifies problems and leads the effort to solve system and sub-system levels issues

• Coordinates the integration efforts between hardware, software and mechanical functions including all sub-component interfaces

• Plans and guides verification and validation efforts, including compliance with standards and regulatory guidelines

REQUIREMENTS:

• MSc in Electrical Engineering, Physics or equivalent. PhD an advantage.

• Minimum 7+ years of experience in systems engineering of multidisciplinary electronic products

• Strong analytical and problem-solving skills

• Able to quickly learn and understand new concepts and background information

• Good grasp of system level, low level and their interplay

• Strong technical background in hardware, software, physics and mechanical design with focus on analog and digital electronics

• Able to write system and project documentation, including plans, design inputs, risk assessment, V&V docs

• Experience in implantable devices, wireless power transfer, systems that involve wearable devices - an advantage

• Able to plan ahead, take decisions and guide team progress

• Able to present ideas clearly and concisely at all levels within the organization

• Strong verbal and written communication skills in English

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 Electrical Engineer

The Senior Electrical Engineer will be responsible for the hardware architecture and design of the Bluewind products from conceptualization to detailed design including, design reviews, technical specifications, implementation, testing and documentation.

RESPONSIBILITIES:

• Responsibility for hardware activities from design considerations and hardware architecture, through technical specifications, design reviews, layouts, detail design documents, risk analysis, testing and documentation

• Translating top level system requirements, standards and regulatory guidelines into hardware architecture and detailed design considerations, taking into account performance, manufacturability, reliability considerations

• Leading hardware projects scoping and planning

• Serves as a source of knowledge and key focal point for electrical engineering aspects, delivering innovative solutions and leading problem solving

REQUIREMENTS:

• BSc in Electrical Engineering. MSc an advantage.

• Minimum 7+ years of experience in electronic design of multidisciplinary products

• Strong background with analog and digital electronics, power electronics, wireless power transfer and battery-operated devices

• Experience in board design and layout design tools including simulation tools and methods. Knowledgeable in technological aspects of PCB production, inspection and assembly

• Familiar with safety and EMC standards and implications on electronic design

• Knowledgeable in the design and implementation of production testing system

• Experienced in writing hardware design documents, including specifications, DFMEA, test protocols and reports

• Familiarity with ASIC design and verification process – a major advantage

• Able to plan ahead, take decisions and guide processes

• Able to quickly learn and understand new concepts and background information

• Strong verbal and written communication skills in English

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

SQA & Application Engineer

The Software QA & Application Engineer will take a major role in the verification and validation of the product software as well as provide technical support and trouble-shooting for products in the market. This position reports to the SQA & Application Team Leader and is part of the Bluewind R&D team.

RESPONSIBILITIES:

•Software verification and validation, including protocol creation, manual testing, bug management and reporting

• Providing feedback regarding software bugs and improvement opportunities

• Writing and maintaining documentation (software requirements, testing protocols, instructions etc.)

• Providing technical support, trouble shooting and leading software bug investigation

REQUIREMENTS:

• B.Sc. in Bio-medical engineering or equivalent

• Hands-on experience in Software QA – an advantage

• Experience in medical device companies – an advantage

• Ability to learn and understand new concepts and background information

• Ability to define software requirements and user experience

• Capable of prioritizing tasks and providing a timely schedule of completion

• Creative and flexible in problem solving

• Excellent communicator and team player

• Fluent in English and Hebrew

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

Clinical Research Associate

We are looking for a highly motivated Clinical Research Associate to join our global team and contribute to the success of the clinical operation activity. Candidates must have 1-5 years of experience as CRA from Industry/CRO companies conducting multi-center global studies. We are looking for a detailed oriented team player with excellent communication skills and ability to work independently. This position is reporting to the Director, Clinical Affairs which is based in Israel.

RESPONSIBILITIES:

• Assure study compliance and all safety information is reported appropriately

• Assure accurate, complete and current records are maintained

• In house data review of eCRF, including query management

• Maintain communication with sites

• Train clinical site personnel and investigators on protocol and clinical study activities

• Present clinical study updates and summaries in written and oral reports

• Facilitate clinical trial agreement and budget completion

• Local IRB/EC submissions

• Work with site assigned CRO personnel

• Support R&D and medical teams as needed

• Assist with development of clinical trial documents e.g. CRFs, worksheets, ICF

REQUIREMENTS:

• Degree in life science/medicine or similar

• At least 1-5 years experience as CRA

• Prior experience with medical device – advantage

• Experience in project management and demonstrate the ability to meet project requirements.

• Excellent interpersonal skills

• Excellent written and oral communication and presentation skills

• Must work both independently and in a team environment

• Full proficiency with Office software

• Ability to travel abroad

• Fluent verbal and written Hebrew and English

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

Terms & Conditions

Data protection on the BlueWind website

Data protection

Welcome to the BlueWind Website. We appreciate your interest in our company.
Protection of the personal data you entrust to us is a priority for us, and we want you to
feel safe and secure when you visit our website or use our online offers.

It is important to us that you are fully informed about the personal data that we collect
when you use our online offers and services, and are familiar with how we use them.

Wherever BlueWind processes personal data, such processing is carried out for the
purposes defined in this data privacy statement.

Processing of personal data

Visiting our website

We record and save your computer's IP address in order to send the contents of our
website visited by you to your computer (e.g. texts, pictures, and files provided for
downloading, etc.) (cf. Art. 6 (1) lit. b GDPR). We also process these data to identify and
pursue any misuse. Legal basis in this case is Art. 6 (1) lit. f GDPR. In this context, our
legitimate interest in data processing is to ensure the due functioning of our website and
the business transacted via the Website.

Other purposes

We also process personal data that you provide voluntarily, e.g. when you make an
inquiry or online appointment, or when you order information material or newsletters.
Legal basis in this case is Art. 6 (1) lit. b GDPR. The data processed by us in this context
include the data of customers, distributors, suppliers to the extent necessary for the
purposes specified within the scope of this data privacy statement.

In as far as we process your data as described above for the purpose of accepting and
processing your inquiry, appointment, or (newsletter) order, you are contractually
bound to make these data available to us. We are unable to process your request
without the data.

Where you have given your consent to the processing of personal data (cf. Art. 6 (1) lit. a
GDPR), you can withdraw your consent at any time. Withdrawal of consent will not
affect the lawfulness of processing based on consent up to the time of withdrawal of
consent.

Transfer to third parties

We may transfer your data to the relevant supplier or distributor where it is processed to
deliver the service and support you requested.

This means that information may also be processed by other entities. However, such
processing is limited to the extent required for the purposes defined in this data privacy
statement or to which the other legal entity acting as a service provider / processor has to
follow the instructions given by the controller.

These service providers / processors are bound by instructions. Given this, they are
subject to our requirements, which include processing of your data exclusively in line
with our instructions and in compliance with the applicable Data Protection Act. In
particular, they are contractually bound to treat your data with strict confidentiality, and
are not permitted to process data for other purposes than the ones agreed.

Data transfer to the data processor is effected on the basis of Art. 28 (1) GDPR.

We will not sell your data to third parties or otherwise share them for commercial purposes.

Beyond the above, we will transfer your personal data to prosecution authorities and, if
applicable, damaged third parties without your explicit consent where this is necessary
for clarifying illegal use of our services or for legal prosecution. However, such a transfer
will only take place if there is concrete evidence of illegal conduct or misuse. Transfer of
your data may also take place where this contributes to enforcing the conditions of use
or other agreements. We are also under legal obligation to provide information to certain
public bodies on request. These comprise prosecution authorities, authorities

prosecuting offences punishable by a fine, and financial authorities.
The transfer of these data is based on our legitimate interest in fighting misuse,
prosecuting criminal acts, and securing, asserting, and enforcing claims unless
our interests are overridden by your rights and interests in the protection of your
personal data, Art. 6 (1) lit. f GDPR.

Intended data transfer to third countries

At present, data transfer to third countries is not planned. Otherwise we will establish the
required legal conditions. In particular, you will be informed of the respective
recipients or categories of recipients of the personal data in line with the legal
requirements.

Security

BlueWind takes appropriate technical and organizational measures to protect any
personal data you provide to BlueWind from accidental or intentional manipulation,
loss, destruction, or access by unauthorized parties. This also applies to any external
services purchased. We verify the effectiveness of our data protection measures and
continuously improve them in line with technological development.

Cookies

For a user-friendly website experience and to tailor the operations of our website to your
needs, some areas of our website may use cookies. A cookie is a small file that is stored
locally on your computer when you visit a website. When you revisit the website on the
same device, the cookie will indicate, for example, that you are a repeat visitor. Cookies
also allow us to analyze the use of our website. They do not include any personal data
and cannot identify you on third-party websites––including those of analytics providers.

We use the following types of cookies:

Essential/necessary cookies
These cookies are essential for the functioning of our website. This includes,
for example, issue of anonymous session IDs to summarize multiple
queries to a web server, or ensuring fault-free functioning of registrations
and orders.
Functionality cookies
These cookies help us to save your chosen settings or support other functions
when you are navigating our website. They allow us, for example, to
remember your preferred settings for your next visit or save your login data for
certain areas of our Website.
Targeting/Third Party Cookies
These cookies are for analytical purposes and are anonymized and
analyzed by third parties.

Standard periods for deletion of data:

Legislation has defined numerous data storage periods and obligations. At the end of
these periods, the relevant data will be routinely deleted. Data that are not affected by
the above storage periods and obligations are deleted or anonymized as soon as the
purposes defined in this data privacy statement no longer apply. Unless this data
privacy statement includes other deviating provisions for data storage, we will store
any data we collect for as long as they are required for the above purposes for which
they were collected.

Other data use and deletion of data

Any further processing or use of your personal data will generally only be carried out to
the extent permitted on the basis of a legal regulation or where you have consented to
data processing or data use. In the case of further processing for other purposes than
the ones for which the data were originally collected, we will inform you about these
other services and provide you with all other significant information before further
processing.

Rights concerning the processing of personal data.

Right of access

On request, you have the right to obtain information from us about the personal data
concerning you and processed by us, to the extent defined in Art. 15 GDPR. You can
send your request either by mail or email to the addresses given below.

Right to rectification

You have the right to require us to rectify any inaccurate personal data concerning
you without undue delay (Art. 16 GDPR). For this purpose, please contact the
address given below.

Right to deletion

Where the legal reasons defined in Art. 17 GDPR apply, you have the right to immediate
deletion (“right to be forgotten”) of personal data concerning you. These legal reasons
include: the personal data are no longer necessary for the purposes for which they were
processed, or you withdraw your consent, and there are no other legal grounds for
processing; the data subject objects to the processing (and there are no overriding
legitimate grounds for processing––does not apply to objections to direct advertising).
To assert your above right, please contact the contact address given below.

Right to restriction of processing

If the criteria defined in Art. 18 GDPR are fulfilled, you have the right to restriction of
processing as established in the above article of the GDPR. According to this article,
restriction of processing may be called for in particular if processing is unlawful and the
data subject opposes deletion of the personal data and requests the restriction of their
use instead, or if the data subject has objected to processing according to Art. 21 (1)
GDPR as long as it is unclear whether our legitimate interest overrides the interest of the
data subject. To assert your above right, please contact the contact address given
below.

Right to data portability

You have the right to data portability as defined in Art. 20 GDPR. This means you
have the right to receive the personal data concerning you, which you have provided to
us, in a structured, commonly used, and machine-readable format, and have the
right to transmit those data to another controller, such as another service provider.
Prerequisite is that processing is based on consent or a contract, and is carried out
using automated means. To assert your above right, please contact the contact
address given below.

Right to object

You have the right to object at any time under Art. 21 GDPR to processing of personal
data concerning you which is based on Art 6 (1) lit. e or f GDPR, on grounds relating to
your particular situation. We will desist from processing your personal data unless we
can demonstrate compelling legitimate grounds for processing which override your
interests, rights, and freedoms, or unless processing is for the establishment, exercise,
or defense of legal claims. To assert your above right, please contact the contact
address given below.

Right to file a complaint with a supervisory authority

If you think that processing of personal data concerning you and carried out by us is
unlawful or impermissible, please contact us.

Please address any questions regarding the processing of your personal data,
requests for information, applications, or complaints directly to our data protection
officer, who will be happy to be of service

If you wish to make use of your right to information on the personal data we process on your
behalf, you may contact us in the following contact details

BlueWind Medical
PO Box 4101
4614002 Herzeliya, IL
Tel.: +972-74-7218900
FAX: +972-74-7218999
E-Mail: info@bluewindmedical.com

Amendment of this data privacy statement

In case an update requires an adaptation of this Privacy Policy, we therefore reserve the
right to amend the current Privacy Policy. The current version is dated November 19,
2018