R&D Systems Engineer (Medical Devices) - On W2

Position Overview

We are seeking an experienced Senior R&D Systems Engineer to join Client's Electrophysiology division in Plymouth, MN.

The selected candidate will support the development of innovative medical devices, specifically new product development involving left atrial appendage occlusion (LAAO) implants and delivery systems.

This role requires a strong background in systems engineering, requirements development, experimental design, and cross-functional technical execution within a regulated medical device environment.

The ideal candidate will be analytical, proactive, and comfortable translating clinical insights, physician feedback, and user needs into actionable engineering requirements.

Key Responsibilities

• Lead and support systems engineering activities for new medical device product development.
• Translate user needs, clinical insights, physician feedback, and engineering data into measurable system and subsystem requirements.
• Develop and support system architecture and requirements traceability.
• Plan and execute experiments, collect technical data, and perform statistical analysis.
• Utilize tools such as Minitab, JMP, or similar statistical analysis software.
• Lead technical investigations, identify technical risks, and recommend engineering solutions.
• Collaborate with cross-functional teams, including R&D, Clinical Engineering, Human Factors Engineering, Design Assurance, and Marketing.
• Participate in laboratory activities, technical discussions, and physician interactions to gather user feedback.
• Support design controls, risk management processes, requirements management, and product development documentation.
• Independently identify technical challenges, define next steps, and communicate recommendations to project leadership.

Required Qualifications

• Bachelor's degree or equivalent in an Engineering discipline.
• Hands-on experience in Systems Engineering and R&D within the medical device or regulated product development industry.
• Experience with requirements development, system architecture, and translating user needs into engineering requirements.
• Experience with experimental design, data collection, and statistical analysis.
• Working knowledge of Minitab, JMP, or similar statistical tools.
• Experience leading technical investigations and working with cross-functional engineering teams.
• Ability to independently drive technical activities with limited supervision.
• Strong analytical, problem-solving, communication, and technical documentation skills.

Preferred Qualifications

• Experience with implantable medical devices or Class III medical devices.
• Experience in Electrophysiology, Structural Heart, Cardiovascular, or catheter-based medical device development.
• Experience with electromechanical medical devices.
• Knowledge of echocardiography imaging modalities such as TEE or ICE.
• Experience in anatomical modeling and anatomical model development.
• Familiarity with 3Mensio, SolidWorks, or similar engineering/modeling tools.
• Experience gathering physician feedback and translating clinical requirements into product user needs.

Work Environment

• 100% onsite in Plymouth, MN.
• 8 hours per day / 40 hours per week.
• No travel required.
• Collaborative R&D environment with significant cross-functional interaction.

Additional Information

• 12+ month contract with potential extension.
• Potential opportunity for full-time conversion based on business needs and performance.

Interested candidates: Please share your updated resume along with your contact details, current location, and availability.

Note: This is a W2 contract opportunity. Candidates must be able to work onsite in Plymouth, MN.

Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.

At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.

Kyyba is an Equal Opportunity Employer.

Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other b