Advantage Technical
Senior Research and Development Engineer
Advantage Technical, Osseo, Minnesota, United States, 55311
Overview
Advance your career with Advantage Technical and our trusted partner in the medical device industry. We are currently seeking a Senior Research and Development Engineer to join our innovative and driven team. In this role, you\'ll contribute to producing high-quality products in a fast-paced, collaborative environment where your skills and dedication are valued. Pay: $70/hr. Schedule: 8:00am - 4:30pm. Key Responsibilities
Develop, validate, and document test methods to support product verification, ensuring accuracy, repeatability, and compliance with standards (ISO 10555, ISO 13485, 21 CFR 820.30, etc.). Apply risk-based thinking to identify and control variability in test methods, equipment, and operator performance. Collaborate with R&D, Design, Packaging, and Quality teams to align test methods with product design requirements and assess impact of design/process changes. Support regulatory compliance and validation activities, maintaining traceability to design specifications, risk analyses, and verification plans. Train laboratory staff on validated test methods, equipment calibration, and safety procedures. Contribute to risk management documentation (hazard analysis, DFMEA, task analysis, software FMEA) and resolve quality issues using systematic problem-solving. Advise management on improvements to quality systems, processes, and products. Required Qualifications
Bachelor\'s degree in engineering, physics, math, or related science. 4+ years\' experience in design quality, R&D, or product development within Medtech/regulatory industries. Knowledge of ISO 13485, ISO 14971, 21 CFR 820, EU MDR, and industry standards (IEC 60601, IEC 62304). Strong analytical, collaborative, and problem-solving skills with ability to navigate ambiguity. Willingness to travel (
Preferred Qualifications
Experience with Single Use Device (SUD) development and Class III medical devices. Test method generation and validation (variable and attribute). Familiarity with risk management tools such as hazard analysis and FMEA. Experience working in highly matrixed, global teams. Benefits
Our benefits package includes medical, dental, vision, and pet insurance, a 401(k) retirement savings plan, Employee Assistance Program (EAP), commuter/parking accounts, Health Savings Account (HSA), and AD&D insurance, and People Perks (additional employee discounts). Application and Notices
If you\'re ready to take the next step in your professional journey, click "Apply Now" and become part of a team committed to excellence and your success. Note: The law requires employers to disclose in each job posting the starting salary range and a general description of all benefits and other compensation to be offered where applicable. After you have applied, download our StaffNOW/WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play. About Advantage Technical
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. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing across North America. Advantage Technical is an equal employment opportunity employer. We provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. We are an E-Verify employer.
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Advance your career with Advantage Technical and our trusted partner in the medical device industry. We are currently seeking a Senior Research and Development Engineer to join our innovative and driven team. In this role, you\'ll contribute to producing high-quality products in a fast-paced, collaborative environment where your skills and dedication are valued. Pay: $70/hr. Schedule: 8:00am - 4:30pm. Key Responsibilities
Develop, validate, and document test methods to support product verification, ensuring accuracy, repeatability, and compliance with standards (ISO 10555, ISO 13485, 21 CFR 820.30, etc.). Apply risk-based thinking to identify and control variability in test methods, equipment, and operator performance. Collaborate with R&D, Design, Packaging, and Quality teams to align test methods with product design requirements and assess impact of design/process changes. Support regulatory compliance and validation activities, maintaining traceability to design specifications, risk analyses, and verification plans. Train laboratory staff on validated test methods, equipment calibration, and safety procedures. Contribute to risk management documentation (hazard analysis, DFMEA, task analysis, software FMEA) and resolve quality issues using systematic problem-solving. Advise management on improvements to quality systems, processes, and products. Required Qualifications
Bachelor\'s degree in engineering, physics, math, or related science. 4+ years\' experience in design quality, R&D, or product development within Medtech/regulatory industries. Knowledge of ISO 13485, ISO 14971, 21 CFR 820, EU MDR, and industry standards (IEC 60601, IEC 62304). Strong analytical, collaborative, and problem-solving skills with ability to navigate ambiguity. Willingness to travel (
Preferred Qualifications
Experience with Single Use Device (SUD) development and Class III medical devices. Test method generation and validation (variable and attribute). Familiarity with risk management tools such as hazard analysis and FMEA. Experience working in highly matrixed, global teams. Benefits
Our benefits package includes medical, dental, vision, and pet insurance, a 401(k) retirement savings plan, Employee Assistance Program (EAP), commuter/parking accounts, Health Savings Account (HSA), and AD&D insurance, and People Perks (additional employee discounts). Application and Notices
If you\'re ready to take the next step in your professional journey, click "Apply Now" and become part of a team committed to excellence and your success. Note: The law requires employers to disclose in each job posting the starting salary range and a general description of all benefits and other compensation to be offered where applicable. After you have applied, download our StaffNOW/WorkNOW App to receive real-time job offers and apply for additional opportunities. You can download it from the App Store or get it on Google Play. About Advantage Technical
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. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing across North America. Advantage Technical is an equal employment opportunity employer. We provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. We are an E-Verify employer.
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