Mechanical Engineer

Mechanical Engineer – Engineering Lead (EU MDR Remediation)

This role serves as the Engineering Lead for a long-term EU MDR remediation project with a leading medical device organization. In this remote consulting position, you will guide the engineering workstream through two critical phases:
Gap Assessment and Technical File Remediation. You will evaluate existing technical documentation, identify compliance gaps, and drive remediation activities to ensure full alignment with EU MDR requirements. In the second phase, you will lead a team of engineers to execute remediation tasks efficiently, ensuring technical files and related documentation are complete, accurate, and compliant.

• Lead the engineering evaluation of existing technical documentation to assess current compliance status.
• Identify gaps in technical documentation and processes with respect to EU MDR regulations.
• Collaborate with cross-functional teams to gather, validate, and analyze engineering data needed for remediation.
• Provide clear and informed technical input to support quality and regulatory teams throughout the project.
• Drive the engineering remediation of technical files to ensure they meet EU MDR standards and expectations.
• Lead and manage a team of engineers, assigning tasks, monitoring progress, and ensuring timely completion of remediation activities.
• Ensure all engineering documentation is complete, accurate, traceable, and aligned with applicable regulatory requirements.
• Coordinate closely with quality and regulatory stakeholders to align on deliverables, timelines, and priorities across project phases.
• Support the development and maintenance of design history files (DHFs), risk management documentation, and product development records as needed for remediation.
• Promote consistent engineering practices and documentation standards across the team to maintain high-quality outputs.

• Bachelor's degree in Engineering, such as Biomedical, Mechanical, Electrical, or a related discipline.
• Minimum 7 years of experience in medical device engineering.
• Strong understanding of EU MDR requirements and associated technical documentation needs.
• Proven experience leading engineering teams on regulatory or remediation projects within the medical device industry.
• Familiarity with design history files (DHFs), risk management practices, and product development processes.
• Excellent communication skills, with the ability to convey complex technical information clearly to diverse stakeholders.
• Strong leadership capabilities, including team coordination, mentoring, and decision-making.
• Effective organizational skills, with the ability to manage multiple work streams, deadlines, and priorities in a structured manner.

• Prior consulting experience in medical device regulatory or compliance projects.
• Experience working with ISO standards relevant to medical devices.
• Familiarity with 21 CFR Part 820 and associated quality system regulations.
• Proficiency in document control systems used for managing technical files and quality documentation.
• Proficiency with engineering tools and platforms used for design, analysis, and documentation management.

This is a remote consulting role supporting a long-term EU MDR remediation project for a medical device organization. You will collaborate virtually with cross-functional teams including engineering, quality, and regulatory professionals across different locations. The work involves extensive use of digital document control systems, engineering tools, and collaboration platforms to review, update, and manage technical documentation. Hours are typically aligned with standard business operations, with flexibility to accommodate project…