Inspire Medical Systems · 6 hours ago
Quality Engineer, Post Market Surveillance
Minneapolis, MN
Full-time
Onsite
Senior Level
$72K/yr - $107K/yr
5+ years expInspire Medical Systems is pioneering a medical device aimed at improving the lives of those with Obstructive Sleep Apnea. The Quality Engineer will provide expertise in post market surveillance, leading processes such as complaint handling and product analysis while collaborating with various teams to ensure compliance with quality standards.
BiotechnologyHealth CareMedical DeviceTherapeutics
Responsibilities
Lead product reporting process (complaint handling) as assigned, for all Inspire products. This may include the initial evaluation, escalation, risk evaluation, investigation, root cause determination, product disposition and report closure
Manage the returned product analysis process, including decontamination, external vendor sterilization, root cause analysis and root cause determination along with supporting other root cause analyses as
Lead failure mode determination, which may include working with external labs
Manage and collect data on returned product results as well as post market therapy outcomes stemming from the product reporting process
Organize and lead reviews with Development, Operations and Manufacturing on emerging quality issues and participate in any resulting corrective actions
Work with Operations to obtain product returns from the field and initiate warranty replacements
Lead/participate in post market reviews such as: product performance, therapy performance, safety and system risk management
Lead/participate in post market risk management reviews with cross-functional teams to assure risks are minimized and potential CAPAs are initiated
Lead/support cross-functional teams to resolve quality issues and complete CAPAs
Generate and approve design history file documents, device master record documents, ECOs and other QMS records
Support QMS audits with both internal and external auditors
Ability to perform design reliability, process and product quality assurance functions
Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed
Complete training requirements and competency confirmations as required for this position within the required timeline
Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement
Qualification
Required
Bachelor's degree in a technical or scientific field, preferably an engineering discipline such as Electrical, Mechanical, Materials or Biomedical
5 - 10 years minimum experience in quality or design function in the finished medical device industry
Demonstrated team leadership skills and ability to prioritize, execute and report on projects
Experience with risk management tools such as; dFMEA, pFMEA, and FTA
Experience with risk management standard ISO14971
Experience with GHTF requirements for process validations, etc
Knowledge on ISO and FDA/Quality System Requirements. (e.g. ISO 13485; ISO 14969; FDA 21 CRF Part 820, 821, 822)
Strong project and time management skills
Demonstrated creative and effective problem solving and original thinking for compliance solutions
Ability to work on multiple tasks concurrently with changing priorities
Proficient with of MS Word, Excel and PowerPoint
Preferred
Master's degree in a technical or scientific field
Experience in design reliability, process and product quality assurance functions
Experience with Class III active implantables
ASQ certifications; CRE, CQM, CQE, CQA etc
ISO 14971 training
Experience with industry standards such as; IEC 60601, EN 45502, etc
ISO 13485 certified auditor or RAB auditor
Benefits
Multiple health insurance plan options.
Employer contributions to Health Savings Account.
Dental, Vision, Life and Disability benefits.
401k plan + employer match.
Identity Protection.
Flexible time off.
Tuition Reimbursement.
Employee Assistance program.
Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.
Company
Inspire Medical Systems
Inspire Medical Systems develops implantable therapeutic devices for the treatment of obstructive sleep apnea.
1001-5000 employees
H1B Sponsorship
Inspire Medical Systems has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (3)
2023 (2)
2022 (2)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$319.4MKey Investors
Guggenheim Securities,SVB SecuritiesAmzak Capital ManagementOrbiMed
2020-04-13Post Ipo Equity· $133.4M
2018-12-18Post Ipo Equity· $75M
2018-05-03IPO
Leadership Team
Tim Herbert
Chairman & CEO
Richard Buchholz
CFO
Recent News
2026-01-07
Company data provided by crunchbase