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 design quality engineer to take control of his/ her future and help propel the company and set new industry standards.

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You must be the one we are expecting!

As Senior Design Quality Engineer, you will be working with the product, platform, and software engineering team to provide design control and software/systems development guidance. You will be the Design Quality Assurance representative in regulated development activities for various IOT devices solutions.

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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...

  • Act as a leader in bringing the culture of quality in electronic hardware and software medical device development.
  • Collaborate with engineering functions to ensure quality standards are in place.
  • Conduct evaluation of systems activities including requirements, design, development, documentation, integration, test, verification and validation.
  • Define appropriate measures to ensure product quality.
  • Provide guidance to Engineering staff and other personnel and ensures that Design Control requirements are being met in an effective manner, including Design Input/Output, Design Verification/Validation, Risk Management, Test Method Validation and Component Qualification. Compile and analyze performance reports and process control statistics.
  • Work with the Product Development team to ensure all aspects of Design Transfer activities are being met and comply with the requirements of the quality management system and external regulatory agencies.
  • Review proposed changes by performing risk assessments, providing guidance, support, and assessing the adequacy of verification and validations and DHF documents.

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  • Develop the risk management plan for new projects, including translation of product description requirements into hazard assessment, design trace matrix development, Product V&V testing, and FMEA.
  • Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Design and develop systems and processes verification and validation strategies.
  • Plan and conduct in-house activities required to support product/process approvals.
  • Plan and oversee third party activities required for product/process approvals; typically involving EMC or other environmental/type testing.
  • Assist with quality planning activities to ensure design control and risk management compliance according to regulations.
  • Conduct and document assessments of products/designs in support of approval activities, e.g., electrical safety assessments, product Technical Files.
  • 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.

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Here’s what it takes

  • Bachelor’s Degree in Engineering, Science or technical field (Electrical/Electronic, Control systems, or Computer Science Engineering) with 3+ years of work experience in Engineering and/or Quality preferably in the field of IoT systems

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  • Demonstrated applied expertise in EU Medical Device Directives and FDA design control requirements (21 CFR 820.30) as applied to medical device software, electronic and medical device regulations including ISO 13485, ISO 14971, Cybersecurity, and IEC 62304, ISO 60601
  • Experience in design controls and medical device research and product development.
  • Experience with Risk Management

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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 4 months 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 design quality engineer to take control of his/ her future and help propel the company and set new industry standards.

You must be the one we are expecting!

As Senior Design Quality Engineer, you will be working with the product, platform, and software engineering team to provide design control and software/systems development guidance. You will be the Design Quality Assurance representative in regulated development activities for various IOT devices solutions.

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…

  • Act as a leader in bringing the culture of quality in electronic hardware and software medical device development.
  • Collaborate with engineering functions to ensure quality standards are in place.
  • Conduct evaluation of systems activities including requirements, design, development, documentation, integration, test, verification and validation.
  • Define appropriate measures to ensure product quality.
  • Provide guidance to Engineering staff and other personnel and ensures that Design Control requirements are being met in an effective manner, including Design Input/Output, Design Verification/Validation, Risk Management, Test Method Validation and Component Qualification. Compile and analyze performance reports and process control statistics.
  • Work with the Product Development team to ensure all aspects of Design Transfer activities are being met and comply with the requirements of the quality management system and external regulatory agencies.
  • Review proposed changes by performing risk assessments, providing guidance, support, and assessing the adequacy of verification and validations and DHF documents.

  • Develop the risk management plan for new projects, including translation of product description requirements into hazard assessment, design trace matrix development, Product V&V testing, and FMEA.
  • Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
  • Design and develop systems and processes verification and validation strategies.
  • Plan and conduct in-house activities required to support product/process approvals.
  • Plan and oversee third party activities required for product/process approvals; typically involving EMC or
    other environmental/type testing.
  • Assist with quality planning activities to ensure design control and risk management compliance according to regulations.
  • Conduct and document assessments of products/designs in support of approval activities, e.g., electrical safety assessments, product Technical Files.
  • 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.

Here’s what it takes

  • Bachelor’s Degree in Engineering, Science or technical field (Electrical/Electronic, Control systems, or Computer Science Engineering) with 3+ years of work experience in Engineering and/or Quality preferably in the field of IoT systems

  • Demonstrated applied expertise in EU Medical Device Directives and FDA design control requirements (21 CFR 820.30) as applied to medical device software, electronic and medical device regulations including ISO 13485, ISO 14971, Cybersecurity, and IEC 62304, ISO 60601
  • Experience in design controls and medical device research and product development.
  • Experience with Risk Management

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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