Compliance Engineer I – Medical Device

Engineering Resource Group, Inc.; Clifton (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

Engineering Resource Group, Inc. is seeking an entry-level engineer for a long-term contract position to support standards compliance assessment, review board coordination and action item closure for medical device products.

You will prepare, route and track standards assessment records, ensuring inputs, rationale, objective evidence, and decisions are documented and advanced through the defined workflow. You will manage compliance action items from intake through closure, including

Qualifications

• BS Engineering required.
• Minimum 1 year of experience in medical device or comparable regulated product development, quality or regulatory compliance.
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820 documentation, evidence retention and traceability practices.
• Ability to interpret technical at a first level, identify inconsistencies and elevate to engineers or subject-matter experts when deeper judgment is required.
• Experience driving action items, meeting outputs and cross-functional follow-ups to closure within a controlled quality system.
• Experience using approved AI tools with independent verification of output and protection of confidential information.
• Familiarity with device consensus standards such as ISO 14971, IEC 60601 series, IEC 62304 or ISO 10993 a plus.
• Exposure to EU MDR or MDSAP submissions a plus.

Responsibilities

• Long-term contract position for an entry-level engineer supporting standards compliance assessment, review board coordination and action item closure for medical device products.
• Prepare, route and track standards assessment records, ensuring inputs, rationale, objective evidence, technical feedback and decisions are documented and advanced through the defined workflow.
• Manage assigned compliance action items from intake through closure, including clarification, assignment, due dates, status reporting and escalation of blockers.
• Perform first-level review of submissions from design engineering, regulatory affairs, quality and standards personnel for completeness, consistency and traceability to design controls and risk management records.
• Apply approved AI tools to first-line compliance screening to summarize inputs, flag potential gaps and organize preliminary observations, verifying all output independently before routing conclusions for technical review.
• Support the standards review board by preparing agendas, facilitating routine portions of meetings, recording decisions and tracking follow-up items.
• Coordinate with systems engineering, regulatory affairs, quality and technical subject-matter experts to gather inputs and maintain progress on assigned compliance activities.
• Maintain auditable records of compliance requests, technical rationale, decision history, evidence and open actions in support of design history file and technical file deliverables.
• BS Engineering.
• Minimum 1 year of experience in medical device or comparable regulated product development, quality or regulatory compliance.
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820 documentation, evidence retention and traceability practices.
• Ability to interpret technical at a first level, identify inconsistencies and elevate to engineers or subject-matter experts when deeper judgment is required.
• Experience driving action items, meeting outputs and cross-functional follow-ups to closure within a controlled quality system.
• Experience using approved AI tools with independent verification of output and protection of confidential information.
• Familiarity with device consensus standards such as ISO 14971, IEC 60601 series, IEC 62304 or ISO 10993 a plus.
• Exposure to EU MDR or MDSAP submissions a plus.

Skills

Standards compliance

Regulatory review

Cross-functional collaboration

First-level technical review

AI tool usage

Documentation and record-keeping

Education

BS Engineering

Tools

ISO 13485

FDA 21 CFR 820

Job description

• Long-term contract position for an entry-level engineer supporting standards compliance assessment, review board coordination and action item closure for medical device products.
• Prepare, route and track standards assessment records, ensuring inputs, rationale, objective evidence, technical feedback and decisions are documented and advanced through the defined workflow.
• Manage assigned compliance action items from intake through closure, including clarification, assignment, due dates, status reporting and escalation of blockers.
• Perform first-level review of submissions from design engineering, regulatory affairs, quality and standards personnel for completeness, consistency and traceability to design controls and risk management records.
• Apply approved AI tools to first-line compliance screening to summarize inputs, flag potential gaps and organize preliminary observations, verifying all output independently before routing conclusions for technical review.
• Support the standards review board by preparing agendas, facilitating routine portions of meetings, recording decisions and tracking follow-up items.
• Coordinate with systems engineering, regulatory affairs, quality and technical subject-matter experts to gather inputs and maintain progress on assigned compliance activities.
• Maintain auditable records of compliance requests, technical rationale, decision history, evidence and open actions in support of design history file and technical file deliverables.
• BS Engineering.
• Minimum 1 year of experience in medical device or comparable regulated product development, quality or regulatory compliance.
• Working knowledge of ISO 13485 and FDA 21 CFR Part 820 documentation, evidence retention and traceability practices.
• Ability to interpret technical at a first level, identify inconsistencies and elevate to engineers or subject-matter experts when deeper judgment is required.
• Experience driving action items, meeting outputs and cross-functional follow-ups to closure within a controlled quality system.
• Experience using approved AI tools with independent verification of output and protection of confidential information.
• Familiarity with device consensus standards such as ISO 14971, IEC 60601 series, IEC 62304 or ISO 10993 a plus.
• Exposure to EU MDR or MDSAP submissions a plus.