SANUWAVE · 2 days ago
Design Assurance Engineer
Eden Prairie, MN
Full-time
Onsite
Senior Level
$130K/yr - $145K/yr
5+ years expSANUWAVE is a company that focuses on medical devices, and they are seeking a Design Assurance Engineer to provide critical quality and regulatory oversight. This role is essential for ensuring compliance with internal quality requirements and external regulatory standards throughout the design and development activities of their medical devices.
Medical Device
Responsibilities
Provide guidance and approval for all design control documents, ensuring design inputs, outputs, verification, validation, and changes are properly documented and meet regulatory requirements
Lead and participate in risk management activities (e.g., Hazard Analysis, DFMEA, UFMEA) from product concept through commercialization to ensure appropriate risk mitigation and documentation in the risk management file
Develop, review, and support the execution of design verification and validation plans, protocols, and reports, including test method development and validation activities
Oversee the creation, maintenance, and review of the Design History File (DHF) to ensure completeness, accuracy, and compliance with all applicable standards and regulations
Work closely with R&D, manufacturing, regulatory affairs, clinical, and supplier quality teams to integrate quality and compliance activities throughout the product lifecycle
Support internal and external regulatory audits (e.g., FDA, Notified Bodies) and participate in root cause analysis, CAPA (Corrective and Preventive Action), and non-conformance investigations
Utilize statistical methods and analysis tools (e.g., Minitab) for data analysis, reliability studies, and determining appropriate sample sizes for testing and validation activities
Support the transfer of new products from development to manufacturing, ensuring a seamless and compliant transition
Qualification
Required
Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related technical field) or equivalent discipline is required
5+ years of experience in Quality Assurance or Quality Engineering within the medical device industry
Proven experience with Design Controls, Risk Management (ISO 14971 and 13485), Process Validation, and statistical methods
Strong knowledge of medical device regulations and standards (e.g., 21 CFR 820, ISO 13485)
Strong understanding of quality science principles, including acceptance sampling, SPC, DOE, and root cause analysis
Able to function with urgency in high-pressure situations
Excellent verbal, written communication, especially with development and quality teams
Demonstrated business acumen with the proven ability to work independently as well as collaboratively in a cross-functional team environment
Preferred
ASQ Certified Quality Engineer (CQE) or Certified Quality Manager (CMQ-OE) is highly desirable
Early stage/start up experience strongly preferred
Company
SANUWAVE
As an emerging leader in the development and commercialization of energy transfer technology, SANUWAVE presents products that help expedite wound healing on a cellular level.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Morgan Frank
CEO/Chairman Of The Board Of Directors
Pete Stegagno
Chief Operating Officer
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