Design Assurance Engineer

Design Assurance Engineer

This hands-on Design Assurance Engineer position focuses on leading an ISO-compliant risk management remediation initiative within a regulated medical device environment. You will take ownership of remediation planning and execution, drive alignment of risk management activities with design controls and post-market surveillance, and close identified gaps to ensure compliance readiness. The role is highly execution-focused and well-suited for a contributor who enjoys personally remediating risk files, updating procedures, and collaborating closely with cross-functional teams in a fast-paced, compliance-driven setting.

Responsibilities

• Lead end-to-end remediation of risk management processes and risk files to ensure alignment with ISO-based risk management requirements and current regulatory expectations.
• Plan, own, and execute the overall risk remediation strategy, including defining deliverables, timelines, and priorities for closing identified gaps.
• Review, update, correct, and complete existing risk files to address deficiencies and ensure they meet compliance and audit readiness standards.
• Integrate risk management activities with design controls, Design History Files (DHFs), and product lifecycle documentation to maintain traceability and consistency.
• Collaborate closely with Quality Assurance, Regulatory Affairs, Engineering, and Post-Market Surveillance teams to gather inputs and ensure risk documentation reflects design, regulatory, and field performance information.
• Ensure risk management outputs appropriately incorporate post-market data, including complaints, trending, and corrective or preventive action (CAPA) inputs when applicable.
• Drive documentation-heavy activities with high attention to detail, ensuring all risk-related records are accurate, complete, and audit-ready.
• Support preparation for regulatory inspections, audits, and internal assessments by providing clear, well-structured risk management documentation.
• Identify process improvements in risk management and design assurance practices and contribute to updates of procedures and work instructions.
• Work independently with minimal supervision, taking ownership of remediation deliverables and driving projects to closure within agreed timelines.

Essential Skills

• Minimum of 4 years of robust, hands-on experience in medical device risk management, with a preference for 5–8 years of experience.
• Direct, practical experience applying ISO-based risk management principles in a regulated medical device environment.
• Proven background in risk file remediation, including personally updating, correcting, and closing gaps in risk documentation rather than only providing theoretical guidance.
• Strong understanding of design controls and how risk management activities integrate across the product lifecycle and DHFs.
• Demonstrated experience working cross-functionally with Quality Assurance, Regulatory Affairs, Engineering, and Post-Market Surveillance teams.
• Ability to work independently, manage priorities, and fully own risk remediation deliverables from planning through completion.
• High attention to detail and strong documentation skills suitable for a compliance-driven, documentation-heavy role.

Additional Skills & Qualifications

• Experience supporting FDA and EU MDR regulatory frameworks for medical devices.
• Prior involvement in audit findings, gap assessments, or remediation programs related to risk management or design assurance.
• Exposure to post-market trending, complaints handling, or CAPA processes and how they feed into risk files.
• Comfort operating in a fast-paced environment with clear, outcome-focused deliverables.
• Strong collaboration and communication skills to work effectively with design, regulatory, quality, and post-market teams.

Work Environment

This role operates within a fast-paced, compliance-driven medical device environment that emphasizes rigorous documentation and cross-functional collaboration. The position offers on-site work in Louisville, CO, with flexibility for hybrid or fully remote arrangements, enabling you to contribute effectively regardless of location. You will work closely with design, regulatory, quality, and post-market teams, often engaging in detailed reviews of technical and quality documentation. The environment favors proactive, hands-on contributors who enjoy owning visible compliance initiatives and delivering clear, measurable remediation outcomes.

Job Type & Location

This is a Contract position based out of Louisville, CO.

Pay and Benefits

The pay range for this position is $55.00 - $72.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Jun 9, 2026.