Inspire Medical Systems is looking to ensure the quality and reliability of their medical device software products, particularly in the context of regulatory compliance and design control requirements.
Requirements
- Comprehensive knowledge on medical software device design standards along with global regulations for medical device software design.
- 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.
- Experience with Class III active implantable products.
- Experience with software design reliability, process and product quality assurance functions (preferred)
Responsibilities
- Partner with Development to generate project deliverables and conduct audits of the deliverables prior to product release.
- Ensure design history content integrity, completeness, and regulatory / standards compliance.
- Provide product software design assurance services, including planning for software design validation, design transfer, test system development and validation.
- Partner with Development on the validation of software test environments and software tools.
- Support risk management activities from product concept through commercialization.
- Ensure quality system procedural requirements and development life cycle phases are followed.
- Ensure proper cyber security testing and controls are utilized and documented.
Other
- Bachelor's degree in a technical or scientific field
- 8 years minimum experience a medical device software quality or software design assurance role for finished medical devices.
- Demonstrated team leadership skills and ability to prioritize, execute and report on projects
- Strong project and time management skills
- Ability to work on multiple tasks concurrently with changing priorities
- Proficient with of MS Word, Excel and PowerPoint
- ASQ certifications; CSQE, CRE, CQM, CQE, etc. (preferred)
- Experience working with bug tracking tools such as JIRA (preferred)
