Remote Systems Design Engineer

We're seeking a System Design Engineer to assist with a high-priority integration initiative following a major acquisition., Act as the primary bridge between user requirements and technical solutions. Lead the refinement of technical documentation to ensure compliance with medical device regulations. Define design approaches and lead technical reviews, balancing usability with long-term sustainability. Execute hands-on Verification and Validation (V&V) by developing protocols and conducting manual and automated testing. Manage Remediation and Compliance efforts, with a heavy focus on maintaining the Design History File (DHF). Collaborate with Quality Assurance and Regulatory teams to address gaps and meet FDA and ISO standards.

Working hours: 8:00 AM - 5:00 PM

Standards: Knowledge of IEC 62366. Availability: Ability to work a schedule aligned with Mountain Time. Mindset: Ability to "hit the ground running" in a fast-paced, documentation-heavy environment.

Education: Bachelors

Experience: 4-7 years

Qualifications: Experience: Minimum of 5 years in medical device design, specifically with Software as a Medical Device (SaMD).

Education: Bachelor?s degree in Engineering or Science (Biomedical Engineering is highly preferred).

Technical Proficiency: Deep knowledge of Design Controls, DHF maintenance (traceability, design inputs/outputs), and risk analysis including uFMEA.

Standards: Strong familiarity with ISO 14971.

Tools: Proficient in using Codebeamer or Jira for tracking and documentation.

This is a fast-paced, high-impact role, where the primary mission is transferring complex systems into the existing enterprise ecosystem. This position is fully remote and operates as a 6-7 month contract with the potential for long-term extension or conversion to full-time based on performance and business needs.

What's In It For You: Fully Remote Work: Enjoy the flexibility of working from wherever you are most productive. High-Impact Project: Play a critical role in a major acquisition integration for a global orthopedic leader. Technical Growth: Gain experience navigating complex regulatory landscapes and working with sophisticated SaMD technology that will significantly enhance your professional resume. Competitive Compensation: Salary range of $75k-$85k/year