Engineering Lead - EU MDR Remediation

Actalent; Chicago (IL); Remote; USD 150,000 - 200,000; Full time

Job summary

A leading consulting company is seeking an Engineering Lead to support EU MDR remediation efforts in a fully remote position. This role requires substantial experience in medical device engineering and compliance, along with leadership capabilities. Candidates must possess a Bachelor's degree in Engineering and have at least 7 years of relevant experience. The position offers competitive hourly rates and comprehensive benefits including paid time off.

Benefits

Medical, dental & vision benefits

401(k) Retirement Plan

Employee Assistance Program

2 weeks of paid time off

Qualifications

• Minimum 7 years of experience in medical device engineering.
• Experience leading engineering teams in regulatory projects.
• Familiarity with design history files (DHFs) and risk management.

Responsibilities

• Lead the engineering evaluation of existing technical documentation.
• Identify gaps in compliance with EU MDR regulations.
• Drive the engineering remediation of technical files.

Skills

Strong understanding of EU MDR requirements

Excellent communication skills

Ability to manage multiple priorities

Education

Bachelor’s degree in Engineering

Tools

Document control systems

Job description

Overview

Job Title: Engineering Lead - EU MDR Remediation

We are seeking a skilled and proactive Engineering Lead to support a long-term EU MDR remediation project for a leading medical device company. This remote consulting role will be responsible for leading the engineering workstream across two key phases: Gap Assessment and Technical File Remediation. The Engineering Lead will play a critical role in evaluating existing documentation, identifying compliance gaps, and driving remediation activities to ensure alignment with EU MDR requirements. In Phase 2, the Engineering Lead will lead a team of engineers to execute remediation tasks efficiently and effectively.

Responsibilities

• Lead the engineering evaluation of existing technical documentation.
• Identify gaps in compliance with EU MDR regulations.
• Collaborate with cross-functional teams to gather and analyze engineering data.
• Provide technical input to support quality and regulatory teams.
• Drive the engineering remediation of technical files to meet EU MDR standards.
• Lead and manage a team of engineers to execute remediation activities.
• Ensure engineering documentation is complete, accurate, and compliant.
• Coordinate with quality and regulatory teams to align on deliverables and timelines.

Essential Skills

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, or related field).
• Minimum 7 years of experience in medical device engineering.
• Strong understanding of EU MDR requirements and technical documentation.
• Experience leading engineering teams in regulatory or remediation projects.
• Familiarity with design history files (DHFs), risk management, and product development processes.
• Excellent communication, leadership, and organizational skills.

Additional Skills & Qualifications

• Prior consulting experience in medical device regulatory or compliance projects.
• Experience with ISO and 21 CFR Part 820.
• Proficiency in document control systems and engineering tools.
• Ability to work independently and manage multiple priorities in a remote setting.

Work Environment

This position is remote, offering flexibility in managing your work schedule. Enjoy benefits such as 2 weeks of paid time off and 6 paid holidays.

Pay and Benefits

The pay range for this position is $50.00 - $57.00/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 Oct 3, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [e-mail] for other accommodation options.