About The Wayvio Project

Wayvio, a pioneer in the field of smart healthcare devices, is on track to bring innovation to the next level. To reach higher, Wayvio is looking for a talented Product Approval & IoT/Embedded Systems Validation Engineer to take control of his/her future and help propel the company and set new industry standards.
This is the place for those who want to collaborate and those who want to innovate, for those who want to evolve and those who want to solve, for those who care and those who dare, for those who combine passion and ambition to take up great challenges. If you plan to play an active role in changing the dynamics of healthcare industry. You are in the right place.

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You must be the one we are expecting!

We need a dynamic, successful Product Approval & IoT/ Embedded Systems Validation Engineer to join The Wayvio Project.
You will be part of an amazing team and will primarily be responsible for validation and support of the IoT cloud applications as well as the embedded systems for products. Your will be involved in all stages of the development life cycle, from initial concept generation through to final delivery.
We will need you to advise on product approval requirements

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and methods, conduct or overseeing in-house or third-party product approval activities, assess and compile evidence to support product approvals.
If you’re able to work as part of a team to realize complex, innovative, high reliability systems that will allow a more secure and responsible use of medical devices worldwide, this role is for you!

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Your mission, should you choose to accept it...

  • Design and develop verification and validation strategies.
  • Write the DFMEA/ Risk Management Plan at Component (Electronic Chip) & Product level.
  • Plan and conduct in-house activities required to support product approvals.
  • Plan and oversee third party activities required for product approvals typically involving EMC or other environmental/ type testing.
  • Create or oversee test set-up and test spec requirements.
  • Conduct and document assessments of products/designs in support of approval activities, e.g., electrical safety assessments, product Technical Files.

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  • Central role in supporting other systems engineering or test and verification activities, e.g., by providing advice on approval requirements/methods for current or proposed products and projects or supporting the definition of requirements and verification approaches.
  • Support product/project technical authorities and be prepared to justify approval requirements/methods to project management, Regulatory & Quality Management, and potentially the customer or statutory bodies.
  • Contribute when and where ever your feel you have the skills.

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Here’s what it takes

  • BS in Electrical/Electronic, Control systems, or Computer Science Engineering
  • 3-4 years of hands-on experience in design, testing, and validation of IoT systems
  • System functional testing and verification methods and firmware release management
  • Previous experience in application and testing of RF technologies such as Wi-Fi, SigFox/LoRa (WAN), or BLE is preferred
  • Experience in the medical device industry with good knowledge of medical deviceregulations for Electronic Devices and Softwares (21 CFR 820, ISO 13485, ISO 62301, ISO 60601)

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Now for the soft skills...

  • Ability to think strategically and execute methodically.
  • Excellent written and oral communication skills.
  • You are results-oriented, upbeat and focused with a strong passion to learn and succeed.
  • Self-motivated, entrepreneurial, independent, driven individual to meet objectives.
  • Ability to multitask and prioritize while managing multiple projects and day to day responsibilities
  • Ability to influence cross-functional teams without formal authority.
  • Strong attention to detail and an ability to deal with ambiguity

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Apply for this Job

Full time
Chicago area
Posted 1 month ago

About The Wayvio Project

Wayvio, a pioneer in the field of smart healthcare devices, is on track to bring innovation to the next level. To reach higher, Wayvio is looking for a talented Product Approval & IoT/Embedded Systems Validation Engineer to take control of his/her future and help propel the company and set new industry standards.
This is the place for those who want to collaborate and those who want to innovate, for those who want to evolve and those who want to solve, for those who care and those who dare, for those who combine passion and ambition to take up great challenges. If you plan to play an active role in changing the dynamics of healthcare industry. You are in the right place.

You must be the one we are expecting!

We need a dynamic, successful Product Approval & IoT/ Embedded Systems Validation Engineer to join The Wayvio Project.
You will be part of an amazing team and will primarily be responsible for validation and support of the IoT cloud applications as well as the embedded systems for products. Your will be involved in all stages of the development life cycle, from initial concept generation through to final delivery.
We will need you to advise on product approval requirements

and methods, conduct or overseeing in-house or third-party product approval activities, assess and compile evidence to support product approvals.
If you’re able to work as part of a team to realize complex, innovative, high reliability systems that will allow a more secure and responsible use of medical devices worldwide, this role is for you!

Your mission, should you choose to accept it…

  • Design and develop verification and validation strategies.
  • Write the DFMEA/ Risk Management Plan at Component
    (Electronic Chip) & Product level.
  • Plan and conduct in-house activities required to support
    product approvals.
  • Plan and oversee third party activities required for product
    approvals typically involving EMC or other environmental/
    type testing.
  • Create or oversee test set-up and test spec requirements.
  • Conduct and document assessments of products/designs
    in support of approval activities, e.g., electrical safety
    assessments, product Technical Files.

  • Central role in supporting other systems engineering or
    test and verification activities, e.g., by providing advice on
    approval requirements/methods for current or proposed
    products and projects or supporting the definition of
    requirements and verification approaches.
  • Support product/project technical authorities and be
    prepared to justify approval requirements/methods to
    project management, Regulatory & Quality Management,
    and potentially the customer or statutory bodies.
  • Contribute when and where ever your feel you have the
    skills.

Here’s what it takes

  • BS in Electrical/Electronic, Control systems, or Computer Science Engineering
  • 3-4 years of hands-on experience in design, testing, and validation of IoT systems
  • System functional testing and verification methods and firmware release management
  • Previous experience in application and testing of RF technologies such as Wi-Fi, SigFox/LoRa (WAN), or BLE is preferred
  • Experience in the medical device industry with good knowledge of medical deviceregulations for Electronic Devices and Softwares (21 CFR 820, ISO 13485, ISO 62301, ISO 60601)

Now for the soft skills…

  • Ability to think strategically and execute methodically.
  • Excellent written and oral communication skills.
  • You are results-oriented, upbeat and focused with a strong passion to learn and succeed.
  • Self-motivated, entrepreneurial, independent, driven individual to meet objectives.
  • Ability to multitask and prioritize while managing multiple projects and day to day responsibilities
  • Ability to influence cross-functional teams without formal authority.
  • Strong attention to detail and an ability to deal with ambiguity

Apply for this Job

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