Senior Engineer – Quality Design Assurance

Minor Hotels Europe and Americas

Senior Engineer leading quality assurance in medical device development projects, ensuring compliance with regulatory standards and quality systems. Collaborating with cross-functional teams and mentoring junior staff.

Posted 7/28/2026full-timeFridley • Minnesota • 🇺🇸 United StatesSenior💰 $110,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance within the medical device industry, ensuring compliance with regulatory standards such as ISO 13485 and FDA Quality System Regulations. Capable of leading project teams, conducting risk management, and facilitating audits while providing mentorship to junior engineers.

Highest-signal resume keywords

Quality Assurance EngineeringISO 13485 ComplianceFDA Quality System RegulationsRisk ManagementContinuous Improvement Initiatives

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Root-Cause AnalysisDesign ControlsVerification and ValidationInspection StrategiesTest PlansGood Manufacturing PracticesGood Laboratory PracticesSterilization ProcessesCleanroom EnvironmentsProject Management

Soft Skills

Customer-Focused MindsetCollaborative Working AbilityStrong Problem-Solving SkillsOrganizational SkillsTeam-Building Skills

Tools & Technologies

Microsoft WordMicrosoft ExcelMinitab

Industry Keywords

Medical Device IndustryNonconforming Product DispositionsProduct QualityCustomer AuditsRegulatory Audits

About the role

Key responsibilities & impact

Lead project team members supporting the development of complex medical device components
Represent the Quality Assurance function on multiple product and process development projects
Ensure development activities comply with regulatory requirements, customer requirements, and quality standards
Support design controls, risk management, verification and validation activities
Design and specify inspection strategies, test plans, and procedures
Initiate, review, and approve Nonconforming Product dispositions; perform root-cause analysis
Lead continuous improvement initiatives, proposing solutions and improving product quality
Support and interface with engineering, manufacturing, regulatory, quality, and operations teams
Facilitate customer audits and ensure readiness for regulatory audits
Provide mentorship and technical guidance to junior engineers

Requirements

What you’ll need

Bachelor degree in engineering or related field required
Minimum 8 years of relevant experience required; 1 year may be substituted for graduate degree or 3 years for doctorate
Experience in the medical device industry as a Quality Assurance Engineer strongly preferred
Practical experience and familiarity with ISO 13485, FDA Quality System Regulations, Design Controls, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), ISO 14971, sterilization processes, cleanroom environments, and other applicable standards
Customer-focused mindset with collaborative working ability
Must be highly organized and able to manage multiple projects concurrently
Strong independent problem-solving skills
Preferred knowledge related to supported products such as guidewires, catheters, leads, electromechanical devices
Must possess strong written and verbal communication skills, team-building skills, and basic PC skills, including Microsoft Word, Excel, and Minitab
Must be willing and able to travel between Fridley, MN and White Bear Lake, MN.

Benefits

Comp & perks

Comprehensive medical, dental, and vision coverage
401(k) plan with company match
Education reimbursement
Paid parental leave
Paid time off
Bonus eligibility with a target of 10%