Jobs in the United States

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Added 6 mins ago
Senior Product Engineer
Toyota
Liberty, NC
Toyota North Carolina's (TBMNC) Central Tech Department is looking for a passionate and highly motivated Senior Product Engineer.
Added 6 mins ago
Field Engineer Lead I
General Atomics
Cherry Point, NC
Must possess the ability to resolve supervisory and technical problems and s
Added 6 mins ago
Manufacturing Specialist
GE Aerospace
West Jefferson, NC
The Manufacturing Engineer at GE Aerospace will play a critical role in ensuring the efficient and timely flow of materials for our aviation products. This position involves managing…
Added 6 mins ago
Sr Materials Controller - BESS - NC Job Details | Black & Veatch Family of Companies
Black & Veatch
Mount Holly, NC
…delivery of project materials and equipment. Manages the OS and D process with supply vendors and coordinates with procurement as needed. Ensures proper creation, filing, and dissemination…
Added 6 mins ago
R&D Design Engineer - Power Distribution Equipment
Siemens
Wendell, NC
Ability to be on-site at the Wendell, NC location a minimum of 3 days per week
Added 7 mins ago
Technical Account Manager 3 - Major Incident Team
NetApp
Morrisville, NC
Candidates must reside within commuting distance from NetApp RTP office and be able to work on-site as required
Added 7 mins ago
Lead Manufacturing Engineer
GE Aerospace
Wilmington, NC
…operations that include product quality, machine programming, process design & sustainment and planning utilizing professional technical discipline. Functions with some autonomy but…
Added 7 mins ago
Member of Product Staff
Meta
Raleigh, NC
Champion AI-native strategies including comprehensive evals and data strategies that enable org-wide continuous improvement.
Added 7 mins ago
Lead Director - Security Operations Center (SOC)
CVS Health
Raleigh, NC
…Through strong leadership, operational discipline, and continuous improvement, this position helps ensure cybersecurity remains an enabler of growth while reducing risk in a highly…
Added 7 mins ago
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Distribution Engineer (Raleigh)
Actalent
Raleigh, NC
- $27 to $30 USD / hour
We are seeking a motivated and detail-oriented Entry-Level Power Distribution Engineer to join a dynamic engineering team. This role is ideal for individuals with an engineering degree who…
Added 8 mins ago
AI/ML Engineer Intern
Intermountain Health
Raleigh, NC
…Intermountain is widely recognized as a leader in clinical quality improvement and efficient healthcare…
Added 8 mins ago
Product Security Engineer - Team Lead
Meta
Raleigh, NC
Product Security Engineer - Team Lead Responsibilities:
Added 8 mins ago
PT
Manufacturing Engineer
PDS Tech Commercial
Charlotte, NC
- $54.04 USD / hour
As a Senior Manufacturing Engineer , you’ll serve as a primary technical resource for air-cooled chiller manufacturing operations. You’ll tackle complex production challenges, develop and…
Added 10 mins ago
B/
Systems Engineer Technical Advisor SETA- Expert (23263)
BE / RenXTech
Chantilly, VA
- $150,000 to $190,000 USD / year
Must have an Active TS/SCI clearance with Polygraph
Added 10 mins ago
NPI Director- Operations Readiness
ServiceNow
San Diego, CA
…launching into market. In addition, this role will drive continuous improvement in operational readiness, and a scaled operating model to deliver quality outcomes that accelerate sales and…
Added 13 mins ago
Industrial Engineer – Battery Manufacturing
K&K Technical
Liberty, NC
We are seeking an experienced Industrial Engineer to support battery manufacturing operations, capital projects, production readiness, and continuous improvement in a high-volume…
Added 18 mins ago
Quality Manager
Stryten Energy
Lithonia, GA
Must have strong problem solving skills
Added 29 mins ago
Engineer (Relay Settings and Configurations)
Entergy
New Orleans, LA
Ability to recognize opportunities for process improvement and have the ability to enact change
Added 29 mins ago
Utility Engineer (Transmission/Lines)
Entergy
Baton Rouge, LA
Ability to recognize opportunities for process improvement and have the ability to enact change.
Added 31 mins ago
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Manufacturing Engineer
Actalent
Royersford, PA
- $80,000 to $90,000 USD / year
Job Title: Manufacturing EngineerJob DescriptionThe Manufacturing Engineer plays a key role in improving product quality and throughput within a production environment. This position…
Added 31 mins ago
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Electrical Engineer
Actalent
Dahlgren, VA
- $80,000 to $100,000 USD / year
The position involves working five days per week on average at NSWC Dahlgren
Added 31 mins ago
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C++ Software Engineer
Actalent
Manassas, VA
- $60 to $90 USD / hour
Contribute to continuous improvement of CI/CD pipelines and software build workflows, with a focus on reliability and scalability.
Added 31 mins ago
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Transportation Project Manager
AECOM
Raleigh, NC
- $140,000 to $185,000 USD / year
Professional Engineer (PE or P.Eng.) license required
Added 36 mins ago
Process Engineer
Thread Craft
Sterling Heights, MI
As a Process Engineer at Thread-Craft, you will help turn customer requirements and engineering drawings into practical, repeatable manufacturing processes. You will work closely with…
Added 45 mins ago
Field Engineer Lead I
General Atomics
Yuma, AZ
Must possess the ability to resolve supervisory and technical problems and s

Actalent

Mechanical Engineer

Warsaw, IN, United States

$55 USD / hour

Apply on careers.actalentservices.com About employer

Applications open in a new tab.

Job details

Pay: $55 USD / hour
Experience: Minimum 7 years of experience in medical device engineering.
Posting language: English
Posted: Nov 13, 2026

Original job description

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.

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:

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

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall 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 applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Apply on careers.actalentservices.com About employer

More about this job

Skills

Documentation
Regulatory compliance
Lead a team
Medical devices
Manage a team
Risk management
Control systems
Communication skills
Leadership
Coaching
Decision making
Time management
Collaboration

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Work requirements

Jobs in the United States