US Tech Solutions
Senior R&D Engineer sought for a 12-month contract position with possible extension, on a W2 contract.
The role involves developing, validating, and continuously improving test methods for product development in the Interventional Oncology and Embolization group.
Job Purpose
The successful candidate will design, develop, and document new test methods, ensuring they are scientifically sound, accurate, and meet applicable standards. Responsibilities
Test Method Development: Design, develop, and document new test methods for product verification. Evaluate the appropriateness and applicability of test methods to measure specifications. Create test instructions following company work instructions and applicable standards. Evaluate measurement accuracy and precision against tolerance requirements. Apply risk-based thinking to identify potential sources of variability or error in test methods. Incorporate controls to ensure measurement accuracy, repeatability, and reproducibility. Evaluate and mitigate risks related to equipment, operator execution, and environmental factors. Design & Technical Integration
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. Validation & Compliance
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. Ensure 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. Requirements
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 ISO 13485 Quality Management Systems, ISO 14971 Risk Management, 21 CFR 820, and EU MDR. Travel approximately
Preferred Qualifications
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. Ability to collaborate and work on a highly matrixed and global team. Experience with Class III Medical Devices. 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.
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The successful candidate will design, develop, and document new test methods, ensuring they are scientifically sound, accurate, and meet applicable standards. Responsibilities
Test Method Development: Design, develop, and document new test methods for product verification. Evaluate the appropriateness and applicability of test methods to measure specifications. Create test instructions following company work instructions and applicable standards. Evaluate measurement accuracy and precision against tolerance requirements. Apply risk-based thinking to identify potential sources of variability or error in test methods. Incorporate controls to ensure measurement accuracy, repeatability, and reproducibility. Evaluate and mitigate risks related to equipment, operator execution, and environmental factors. Design & Technical Integration
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. Validation & Compliance
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. Ensure 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. Requirements
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 ISO 13485 Quality Management Systems, ISO 14971 Risk Management, 21 CFR 820, and EU MDR. Travel approximately
Preferred Qualifications
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. Ability to collaborate and work on a highly matrixed and global team. Experience with Class III Medical Devices. 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.
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