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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!
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.
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.
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.
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.
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.
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.
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.