Sr. Software Design Assurance Engineer

Inspire Medical Systems-posted 3 months ago
$107,700 - $161,500/Yr
Full-time • Mid Level
Golden Valley, MN
1,001-5,000 employees
Miscellaneous Manufacturing
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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.

  • 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.
  • Provide product expertise and guidance on global medical device software and security standards or other specific industry standards to ensure compliance with those standards.
  • Lead and document standard updates and compliance reviews at the prescribed frequency.
  • Provide quality engineering support for design changes, sustaining engineering projects and when applicable supplier changes.
  • Work within a cross-functional team to identify and implement effective controls and support product development from 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.
  • Generate and/or approve the following: DHF deliverables, Engineering Change Orders (ECOs), Risk Management documents and Device Master Record (DMR) deliverables.
  • Provide project direction, coaching, and mentoring for engineering and technical team personnel to ensure best-in-class Software Design Quality Engineering practices.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Support both internal and external audit activities.
  • Support other quality projects and initiatives as assigned.
  • Bachelor's degree in a technical or scientific field.
  • 8 years minimum experience in 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.
  • 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 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.
  • 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.
  • Opportunity to participate in the ownership and success of Inspire through equity awards and the Employee Stock Purchase Program.
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