About

• Our Fortune 500 Medical Device client has an exciting opportunity for a Sr. R&D Engineer.

Job Summary

• We have an exciting opportunity for Senior R&D Engineer within the 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.

Key Responsibilities

• • Test Method Development
• o Design, develop, and document new test methods to support product verification
• o Evaluates the appropriateness and applicability of the test method to measure the specification.
• o Create test instructions following company work instructions and applicable standards (ISO 10555, 21 CFR 820.30, ISO 13485, etc).
• o Evaluates the measurement accuracy and precision against the tolerance requirements.
• • Risk Management & Controls
• o Apply risk-based thinking to identify potential sources of variability or error in test methods.
• o Incorporate controls that ensure measurement accuracy, repeatability, and reproducibility.
• o Evaluate and mitigate risks related to equipment, operator execution, and environmental factors.
• • Design & Technical Integration
• o Collaborate with R&D, Design Engineering, Packaging Engineering and Quality teams to align test methods with product design inputs and requirements.
• o Interpret product design intent to establish relevant test criteria and tolerances.
• o Assess the impact of design or process changes on existing test methods and update documentation accordingly.
• • Validation & Compliance
• o Support test method validation activities via Design Quality.
• o Ensure compliance with internal SOPs, regulatory requirements, and Good Documentation Practices (GDP).
• o Maintain test method traceability to design specifications, risk analyses, and verification plans.
• o Ensures test equipment and instruments are calibrated and qualified, if applicable.
• • Collaboration & Training
• o Partner with Subject Matter Experts (SMEs) for advanced statistical or scientific method development.
• o Train laboratory staff and test users on proper execution of validated test methods.
• o 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.

Required Qualifications

• • 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. 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.

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 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

Other Details

• • Schedule: 08:00:AM - 04:30:PM
• • Work Setup: Onsite in Maple Grove, MN
• • Contract Length: 12 Months
• • Start Date: ASAP
• • Travel approximately