Imricor · 3 months ago
Senior Design Assurance Engineer
Burnsville, MN
Full-time
Onsite
Senior Level
$105K/yr - $130K/yr
5+ years expImricor is seeking a Senior Design Assurance Engineer to support product development and ensure high-quality product delivery. The role involves collaborating with various teams, maintaining compliance with quality management systems, and overseeing design verification and validation processes.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Executes and supports completion of product development deliverables
Creates and supports development of DHF to ensure content is complete, accurate, and compliant with regulatory standards
Supports the development and maintenance of customer requirements, product requirements, and product specifications
Collaborates cross-functionally to lead and support completion and maintenance of product risk management deliverables
Authors design verification and design validation plan and report documents
Implements appropriate sampling inspection and supports qualification activities for purchased components
Supports design test method development, and leads method validation activities
Utilizes statistical techniques to lead and support characterization, verification, and validation testing and root cause analysis
Supports quality system related deliverables including nonconformances and CAPAs
Performs other related duties and responsibilities, as assigned
Qualification
Required
Bachelor of Science in engineering
5+ years' experience in Engineering or Quality in the medical device industry
Must be able to work independently under limited supervision
Advanced knowledge of basic Quality Systems and good documentation practices
Experience in investigating and implementing Corrective and Preventive Actions
Experience in design controls and test method validation
Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO 13485
Strong communication skills, both verbal and written
Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering
Benefits
Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits
Company
Imricor
Imricor Medical Systems, Inc.
51-200 employees
H1B Sponsorship
Imricor 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 (1)
Funding
Current Stage
Public CompanyTotal Funding
$24.98M2023-10-01Post Ipo Equity· $1.29M
2020-02-21Post Ipo Equity· $12.48M
2019-09-11Post Ipo Equity· $0.61M
Leadership Team
Steve Wedan
President and CEO
G
Gregg Stenzel
Chief Operating Officer
Recent News
2026-01-12
MarketScreener
2025-12-15
Company data provided by crunchbase