Mechanical Engineer - Medical Device Manufacturing

Job Description

Job Description

Job Title: Mechanical Engineer (EU MDR Remediation)

Job Description

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.

Responsibilities

• 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.

Essential Skills

• Bachelors degree in Engineering, such as Biomedical, Mechanical, Electrical, or a related discipline.
• 1+ 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 workstreams, deadlines, and priorities 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.
• 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.

Work Environment

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 timelines and coordination with global stakeholders. The environment emphasizes regulatory compliance, structured documentation, and disciplined project execution, providing an opportunity to work on complex medical device products within a highly regulated setting.

Job Type & Location

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

Pay and Benefits

The 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)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 17, 2026.

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.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on us.fitly.work for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.