Inspire Medical Systems is looking to solve the business problem of ensuring product software quality assurance support for new product development projects and design changes, specifically for medical devices designed to treat 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.
- Proficient with of MS Word, Excel and PowerPoint
- Experience with Class III active implantable products.
- Experience with software design reliability, process and product quality assurance functions
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.
- Lead 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
- 12 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
- Flexible time off and tuition reimbursement
