Inspire Medical Systems is looking to solve the business problem of ensuring product software quality assurance support of new product development projects and design changes for their medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA).
Requirements
- Comprehensive knowledge on medical software device design standards along with global regulations for medical device software design.
- 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.
- Proficient with of MS Word, Excel and PowerPoint
- Experience with bug tracking tools such as JIRA.
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; Collaboratively communicating & resolving gaps with cross-functional team members.
- 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, including test methodology, test protocol and acceptance criteria development.
- Support risk management activities from product concept through commercialization.
- Product expertise and guidance on global medical device software and security standards or other specific industry standards to ensure compliance with those standards.
- Ensure proper cyber security testing and controls are utilized and documented
Other
- Associates degree in a technical or scientific field
- 5 years minimum experience with 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
- Bachelor's degree in a technical or scientific field (Preferred)
