Quality Engineer

Job Title: Mechanical Engineer

Job Description

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 2 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

This is a Contract position based out of Largo, FL.

The pay range for this position is $50.00 - $50.00/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)

This is a fully remote position.

This position is anticipated to close on Mar 25, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $50