Careers

Careers

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

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