Design Assurance Manager Jobs

Imricor Medical Systems

Location:
United States, Burnsville

Category:
IT - Administration

Contract Type:
Not provided

Salary:

135000.00 - 165000.00 USD / Year

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Job Description:

The Design Assurance Manager is responsible for managing the design assurance engineering team in the execution of all new product development activities from concept to production launch. This position performs a wide variety of activities to ensure development and continuous production of high-quality products consistent with applicable regulatory requirements, established standards, and customer specifications. This position is responsible for complying with the QMS requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Job Responsibility:

Provides Design Assurance (Design Quality) engineering leadership to directly support medical device development and design changes (Capital Equipment, Software, and Disposables)
Owns and drives deliverables related to Design Controls, Risk Management, Statistical Analysis, and Compliance for product development and commercial design changes
Partners with management across departments to lead quality initiatives to develop and maintain a high performing, scalable, and compliant quality system
Interprets government regulations, agency guidelines, industry standards, and internal policies to ensure compliance
Participates in internal and external audit activities
Hires, trains, and manages employees and their activities to ensure high performance and accountability, collaboration, respect for diversity, and employee job satisfaction
Develops department budget and monitors spending
Performs other related duties and responsibilities, as assigned

Requirements:

Bachelor of Science in a scientific discipline or equivalent education/ training
10+ years of related work experience in roles of increasing responsibility, impact, and scope or an equivalent combination of education and work experience
3+ years’ experience managing people preferred
Class III or Class II medical device experience strongly preferred
Comprehensive knowledge of GMP, ISO 13485, 21 CFR 820, ISO 14971
Strong communication, analytical, and problem-solving skills

Nice to have:

3+ years’ experience managing people preferred
Class III or Class II medical device experience strongly preferred

What we offer:

Medical
Dental
Vision
Health Savings Accounts
Health Care & Dependent Care Flexible Spending Accounts
Disability Benefits
Life Insurance
Retirement Benefits

Additional Information:

Job Posted:
December 09, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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Design Assurance Manager