R&D Engineer IVUS Tech Solutions • Maple Grove, MN, United States
R&D Engineer IV
US Tech Solutions • Maple Grove, MN, United States
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job_description.job_card.job_descriptionWe have an exciting opportunity for Senior R&D Engineer within clients Interventional Oncology and Embolization group. We are seeking a Test Method Development Engineer to support the creation, validation, and continuous improvement of test methods within our product development process. This role requires strong technical expertise in experimental design, risk control, and regulatory compliance. The successful candidate will ensure that test methods are scientifically sound, accurately measure product performance, and meet all applicable standards. Design, develop, and document new test methods to support product verification. Evaluates the appropriateness and applicability of the test method to measure the specification. Create test instructions following company work instructions and applicable standards (ISO 10555, 21 CFR 820.30, ISO 13485, etc). Evaluates the measurement accuracy and precision against the tolerance requirements. Apply risk-based thinking to identify potential sources of variability or error in test methods. Incorporate controls that ensure measurement accuracy, repeatability, and reproducibility. Evaluate and mitigate risks related to equipment, operator execution, and environmental factors. Collaborate with R&D, Design Engineering, Packaging Engineering and Quality teams to align test methods with product design inputs and requirements. Interpret product design intent to establish relevant test criteria and tolerances. Assess the impact of design or process changes on existing test methods and update documentation accordingly. Support test method validation activities via Design Quality. Ensure compliance with internal SOPs, regulatory requirements, and Good Documentation Practices (GDP). Maintain test method traceability to design specifications, risk analyses, and verification plans. Ensures test equipment and instruments are calibrated and qualified, if applicable. Partner with Subject Matter Experts (SMEs) for advanced statistical or scientific method development. Train laboratory staff and test users on proper execution of validated test methods. Provide technical guidance on equipment calibration, setup, and safety requirements. Collaborate with cross-functional design team to support creation and documentation of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis, and Software Design Failure Mode and Effects and Analysis Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Advise management on potential improvements or enhancements to quality systems, processes, and products in the company. Bachelor’s degree in engineering, physics, math, or other science discipline, or equivalent. Minimum of 4 years’ experience in design quality, R&D, or product development engineering in Medtech / regulated industry experience; or equivalent combination of education and experience Understanding and demonstrated use of industry standards (e.g. IEC 60601, IEC 62304). within product design and development process Strong ability to navigate ambiguous situations in a collaborative, innovative, and people-centric team environment. Knowledge of key regulatory requirements including of ISO 13485 Quality Management Systems, ISO 14971 Risk Management, 21 CFR 820, and EU MDR. Travel approximately Experience in Single Use Device (SUD) Development Variable and Attribute Test method generation and validation experience Prior exposure to risk management tools & methodologies such as hazard analysis, FMEA on detailed work with emphasis on accuracy and completeness Ability to collaborate and work on a highly matrixed and global team Experience with Class III Medical Devices
Duration : 12 Months Contract (Possible Extension)
- On W2 Contract
Job Purpose
About the role :
Your responsibilities include :
Test Method Development
Risk Management & Controls
Design & Technical Integration
Validation & Compliance
Collaboration & Training
What we’re looking for in you :
Required Qualifications :
Preferred Qualifications :
About US Tech Solutions :
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To learn more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Name : Kanika Dureja
Email : kanika.d@ustechsolutionsinc.com
Internal Id : 25-48939
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Engineer Iv • Maple Grove, MN, United States
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