Senior Design Assurance Engineer

Senior Design Assurance Engineer | Arden Hills, MN

Join Advantage Technical's team in Arden Hills, MN, and make a lasting impact on healthcare innovation. We're seeking a Senior Design Assurance Engineer. In this high-visibility role, you'll support medical device product development from concept to commercialization and beyond - ensuring our life-changing technologies meet the highest standards of safety, quality, and performance.

Pay: $58 per hour

Schedule: 8:00 AM - 4:30 PM

Key Responsibilities

• Support product development and design quality activities for Active Implantable Medical Devices (AIMD) and accessories
• Apply design engineering principles including DFMEA, Design Verification & Validation, Test Method Validation, and Design Transfer
• Lead or contribute to complex technical issue resolution using Root Cause Analysis, DMAIC, and 5 Whys methodologies
• Review and approve product specifications, verification protocols, and quality documentation
• Drive CAPA initiatives and apply systematic problem-solving to maintain compliance and optimize design performance
• Collaborate cross-functionally with R&D, Regulatory, Manufacturing, Medical Safety, and Post-Market teams
• Champion continuous improvement projects within Design Assurance and Quality functions
• Ensure strict adherence to FDA, ISO 13485, ISO 14971, and MDR quality system regulations
• Uphold company policies and quality standards, maintaining a strong focus on patient safety and product excellence

Minimum Qualifications

• Bachelor's degree in Engineering or related technical field
• 5+ years of relevant experience in the medical device industry
• Strong knowledge of Design Controls, Risk Management, and Quality System Regulations (QSR)
• Proficiency with Microsoft Office Suite
• Proven ability to collaborate across multidisciplinary teams and analyze complex data sets
• Strong technical problem-solving and communication skills

Preferred Qualifications

• Experience in Design Engineering, Process Validation, or Test Method Development
• Hands-on experience writing specifications, test protocols, and technical reports
• Familiarity with DFMEA, DOE, Root Cause Analysis, and CAPA tools
• Exposure to Class III Medical Devices, Electrical Medical Equipment (EME), or Active Implantable Devices (AIMD)
• Strong presentation and leadership skills - able to communicate effectively to technical and non-technical audiences

Employee Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plans
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD & D Insurance

Apply Today

If you're an experienced Design Assurance or Quality Engineer looking for your next professional challenge in the Twin Cities area, we invite you to click "Apply Now" and help shape the future of medical device innovation.

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

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