Engineer II, Standards and Compliance - Defined Term

About the role

The Standards Engineer II supports execution of product standards and compliance activities for complex electro-mechanical and software-driven medical devices. This role provides intermediate-level engineering execution capacity for standards-related work under the guidance of CSA, senior engineers, standards authorities, and technical subject matter experts. The Standards Engineer II uses approved AI tools to support first-line standards and compliance assessment, then applies independent engineering diligence to verify assumptions, identify gaps or inconsistencies, and prepare issues for review and decision-making. The role is expected to exercise developing engineering judgment, manage assigned compliance actions, and drive disciplined follow-through through the Standards Action Board, SAF process, and related compliance workflows. The Standards Engineer II is not expected to serve as the final technical authority for standards interpretation but is expected to recognize when deeper SME review is required and organize the evidence, rationale, and questions needed to support timely decisions.

Responsibilities

• Use approved AI tools to support initial standards and compliance screening, summarize information, identify potential gaps or questions, and organize preliminary observations; independently verify outputs before use and route conclusions through CSA, technical SMEs, and applicable processes.
• Prepare, route, track, and follow up on Standards Assessment Forms or related standards and compliance workflow records, ensuring inputs, rationale, evidence, SME feedback, and decisions are documented and advanced through the defined process.
• Manage assigned standards and compliance action items under guidance, including intake, clarification, ownership tracking, due dates, status updates, and escalation of barriers to closure.
• Review inputs from engineers, CSA, Regulatory, Quality, and other stakeholders for completeness, consistency, traceability, and first-level technical plausibility; identify gaps, unclear rationale, or areas requiring deeper SME interpretation.
• Support Standards Action Board activities by preparing agendas, facilitating routine portions of meetings, documenting decisions and action items, and tracking follow-up to closure.
• Coordinate with CSA, technical SMEs, Systems Engineering, Regulatory Affairs, Quality, and other stakeholders to obtain inputs, align on next steps, and maintain forward progress on assigned compliance activities.
• Maintain clear, organized records of compliance asks, technical rationale, decision history, action status, evidence, and next steps in a manner that is accessible, auditable, and easy for technical owners to use.
• Proactively follow up with action owners, identify overdue or blocked items, communicate status clearly, and help convert compliance priorities into practical execution plans with appropriate guidance.

Requirements

• Bachelor’s degree in Engineering or a closely related technical discipline required or strongly preferred, consistent with an Engineer II role.
• Typically 2–5 years of relevant experience in engineering, medical devices, regulated product development, quality, regulatory, product compliance, or technical project execution.
• Ability to use approved AI tools responsibly to support first-line assessment, while applying independent diligence, verifying outputs, protecting confidential information, and confirming conclusions through appropriate technical review.
• Ability to understand technical inputs at an intermediate level, ask clarifying questions, identify inconsistencies, and engage engineers or SMEs when deeper technical judgment is required.
• Ability to manage action items, meeting outputs, follow-ups, documentation, and cross-functional inputs with strong attention to detail.
• Working familiarity with standards, compliance, design control, quality systems, or regulated product documentation preferred; deep standards subject-matter expertise