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!

Hardware Engineer

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 We are seeking for an outstanding talented HW Engineer, to join our Hardware team in the development of a multidisciplinary medical system and to take responsibility for a broad band of activities throughout the product life cycle. The role requires a deep understanding of digital, analog, RF and power electronic engineering, along with strong hands-on capabilities, proven ability to deep dive into details and specifications, autodidactic approach and R&D methodologies understanding. This position is reporting to the Hardware Team Leader 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:

• Architecture and Board Design

• Verification and Validation

• Transfer to production

• Technical support

 

REQUIREMENTS

• BSc in electrical engineering

• 3-5 years experiences in electronics HW development (Analog, Digital, Power) in highly regulated environment. Experience in OrCAD and Allegro.

• Deep knowledge in R&D methodology and processes (Define Requirements, Specs, Test protocol, Validation and Verification procedures)

• Fluent with lab test equipment

• Familiarity with medical device development- An advantage

• Familiarity with EMC and safety standards

• Understanding of manufacturing processes and working with manufacturing contractors

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

• Team player, independent, fast learner and creative

• Fluent English & Hebrew

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

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

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