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Actalent

Manufacturing Engineer Job at Actalent in Longmont

Actalent, Longmont, CO, United States, 80502

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Actalent is hiring a Manufacturing Engineer in Longmont, CO!

Job Description

We are seeking a highly skilled Validation Engineer with a strong focus on manufacturing and equipment validation to join our team dedicated to continuous improvement in the development of implantable medical devices. The ideal candidate will possess expertise in equipment validation processes such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and have experience working with specialized equipment like lasers and epoxy machines. This position is a contract role.

Responsibilities

  • Support continuous improvement activities within the business
  • Qualify and validate equipment, processes, and protocols for manufacturing development of class 3 medical devices
  • Ensure compliance with relevant industry standards and regulations
  • Collaborate with cross-functional teams to drive process improvements and sustainment efforts

Qualifications

  • Bachelor’s degree in Mechanical Engineering or related field
  • 2-10 years of experience in mechanical design and development
  • Strong technical writing skills
  • Experience with CAD software (SolidWorks, CREO)
  • Familiarity with manufacturing processes and assembly
  • Excellent teamwork, communication, and project management skills
  • Experience with design for manufacturability and reliability principles
  • Experience with design verification and validation, including the use of statistical analysis

Preferred Qualifications

  • Knowledge of design control processes (ISO 13485:2016, FDA regulations)
  • Experience with mechanical design and development within the medical device industry

Work Environment

Medical device manufacturing environment based in Longmont, CO. The facility includes a variety of clean room setups across multiple buildings within the business park. We offer PTO and 11 paid holidays.

Pay and Benefits

The pay range for this position is $35.00 - $52.88/hr.

Requirements

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 specific to your plan or program. Benefits may include:

  • Medical, dental & vision
  • Critical Illness, Accident, and Hospital coverage
  • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions
  • Life Insurance (Voluntary Life & AD&D)
  • Short and long-term disability
  • Health Spending Account (HSA)
  • Transportation benefits
  • Employee Assistance Program
  • Time Off/Leave (PTO, Vacation, Sick Leave)

Workplace Type

This is a fully onsite position in Longmont, CO.

Application Deadline

Anticipated to close on May 29, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help companies advance their initiatives through access to specialized experts. With a network of nearly 30,000 consultants and over 4,500 clients worldwide, Actalent serves many Fortune 500 companies.

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

For reasonable accommodations during the application process, email actalentaccommodation@actalentservices.com.

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