• Principal Design Assurance Engineer

    Insight Global (Golden Valley, MN)


    Job Description

    Insight Global is seeking a Principal Design Assurance Engineer to join the team of a local medial device client. This position is responsible for product software quality assurance support of new product development projects and design changes. This individual will ensure design control requirements are implemented and followed, will support multiple product development projects with a primary focus on software projects. This individual will ensure that the quality objectives are met during the product development and design transfer life cycle. This individual will also be responsible for assessing manufacturing changes ensuring both the design integrity and process control requirements are fulfilled.

     

    This position is responsible for performing tasks that will assure a high level of product reliability along with regulatory compliance and provide technical direction to Inspire staff on matters of quality and compliance throughout the product’s lifecycle. This position will work with Development, Operations, Manufacturing, Regulatory, Quality and other functional areas globally to ensure work is completed in accordance with Inspire procedures and geographic regulations. This is an onsite role working in office Mon-Thurs each week.

     

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

    Skills and Requirements

    •Bachelor’s degree in a technical or scientific field

    •12 years minimum experience a medical device software quality or software design assurance role for finished medical devices.

    •Comprehensive knowledge on medical software device design standards along with global regulations for medical device software design.

    •Demonstrated team leadership skills and ability to prioritize, execute and report on projects A Knowledge on medical device data systems (MDDS)

    •Experience with risk management standard ISO14971 as well as risk management tools such as dFMEA and pFMEA.

    •Knowledge on ISO and FDA/Quality System Requirements. (e.g., ISO 13485; ISO 14969; IEC 62304, FDA 21 CRF Part 820, 821, 822)

    •Experience working with HIPPA and GDPR.

    •Strong project and time management skills

    •Ability to work on multiple tasks concurrently with changing priorities

    •Proficient with of MS Word, Excel and PowerPoint

    •Experience with Class III active implantable products. •Experience in software design reliability, process and product quality assurance functions

    •ASQ certifications; CSQE, CRE, CQM, CQE, etc.

    •Experience working with bug tracking tools such as JIRA.

    •Experience with GHTF requirements for process validations, etc