Mechanical Engineer

Job Title: Engineering Lead EU MDR Remediation (Mechanical Engineer)Job DescriptionThis role offers an opportunity for an experienced engineering professional to lead a long-term EU MDR remediation project for a major medical device organization. As the Engineering Lead, you will oversee the engineering workstream across both the Gap Assessment and Technical File Remediation phases. 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, coordinating closely with quality and regulatory partners to deliver complete, accurate, and compliant technical files in a fully remote consulting capacity.

Responsibilities

• Lead the engineering evaluation of existing technical documentation for medical devices to assess compliance with EU MDR requirements.
• Conduct detailed gap assessments to identify deficiencies in technical files and related engineering documentation.
• Collaborate with cross-functional teams, including quality and regulatory, to gather, interpret, and analyze engineering data.
• Provide clear and well-structured technical input to support quality and regulatory teams in developing compliant documentation and submissions.
• Drive the engineering remediation of technical files to ensure they meet EU MDR standards, including updating and revising documentation as needed.
• Lead and manage a team of engineers, assigning tasks, setting priorities, and monitoring progress to ensure timely completion of remediation activities.
• Ensure all engineering documentation is complete, accurate, traceable, and compliant with applicable regulations and internal procedures.
• Coordinate closely with quality and regulatory teams to align on deliverables, timelines, and project milestones across the remediation program.
• Support the development, maintenance, and improvement of design history files (DHFs), risk management documentation, and product development records as part of remediation.
• Use document control systems and engineering tools to manage, track, and version-control technical documentation throughout the project lifecycle.
• Communicate project status, risks, and issues to stakeholders in a clear and proactive manner, ensuring alignment and transparency.
• Promote best practices in engineering documentation, risk management, and regulatory compliance within the engineering team.

Essential Skills

• Bachelors degree in Engineering, such as Biomedical, Mechanical, Electrical, or a closely related field.
• Minimum 7 years of experience in medical device engineering.
• Strong understanding of EU MDR requirements and associated technical documentation expectations.
• Proven experience leading engineering teams on regulatory or remediation projects within the medical device sector.
• Familiarity with design history files (DHFs), risk management processes, and product development lifecycle for medical devices.
• Excellent communication skills, with the ability to convey complex technical information clearly to cross-functional stakeholders.
• Strong leadership capabilities, including team coordination, mentoring, and decision-making in a project-driven environment.
• Effective organizational and time-management skills, with the ability to manage multiple tasks and deadlines in a structured manner.

Additional Skills & Qualifications

• Prior consulting experience in medical device regulatory or compliance projects.
• Experience working with ISO standards relevant to medical devices.
• Knowledge of 21 CFR Part 820 and quality system regulations.
• Proficiency in document control systems used for managing technical and quality documentation.
• Experience using engineering tools to develop, analyze, and maintain technical documentation and product records.
• Demonstrated ability to operate effectively in a remote, cross-functional project environment.

Work EnvironmentThis is a remote consulting role supporting a long-term EU MDR remediation project for a medical device organization. You will work closely with distributed cross-functional teams, including engineering, quality, and regulatory functions, primarily through virtual collaboration tools. The work focuses on detailed review, analysis, and remediation of technical documentation, including design history files, risk management records, and product development documentation. You will use document control systems and engineering tools on a daily basis to manage and update technical files. The environment emphasizes structured project timelines, clear deliverables, and strong documentation practices, offering a professional setting for an experienced engineer who enjoys leading complex regulatory and compliance initiatives from a remote location. Job Type & LocationThis is a Contract position based out of Warsaw, IN. Pay and BenefitsThe pay range for this position is $55.00 - $55.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.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) Job Type & LocationThis is a Contract position based out of Warsaw, IN. Application DeadlineThis position is anticipated to close on Nov 20, 2026. Workplace TypeThis is a fully remote position.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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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