Mechanical Engineer

Actalent • Louisville, CO • 1h ago

Job Title: Mechanical EngineerJob Description

This role involves supporting a major remediation initiative by updating engineering drawings, executing Test Method Validations (TMVs), and strengthening Design History File (DHF) documentation for acquired product lines. This position is highly hands-on and is best suited for someone experienced in SolidWorks, medical device documentation, and statistical test validation. The successful candidate will update approximately 100 engineering prints, complete around 20 TMVs, and help reduce audit risk by improving DHF and risk-management files. The role requires close collaboration with R&D, Quality, and Manufacturing teams in a dynamic, compliance-driven environment.

Responsibilities

Update approximately 100 engineering prints to current standards, verifying tolerances and accuracy.

Consolidate drawing packages from contract manufacturers.

Execute around 20 Test Method Validations (TMVs), documenting results to FDA/internal standards.

Update Design History Files (DHFs), resolving audit-risk gaps, and reconciling trace matrices and hazard analyses.

Collaborate cross-functionally with R&D, Quality, Manufacturing, and Contract Manufacturers to close documentation gaps.

Essential Skills

3-7 years of engineering experience in medical devices or regulated hardware.

Strong proficiency in SolidWorks and engineering drawing creation/modification.

Demonstrated experience in Test Method Validation (TMV) or equivalent statistical tools.

Familiarity with DHF structure, ISO standards, and remediation activities.

Ability to work on-site in Louisville, CO and independently handle detailed documentation work.

Additional Skills & Qualifications

Experience supporting remediation from 483s, warning letters, or audit findings.

Background in test fixture design.

Experience integrating Contract Manufacturer-generated drawing packages.

Exposure to vessel sealing or stapling devices (nice-to-have, not required).

Work Environment

The position is based on-site in Louisville, CO within the R&D department. The role involves hands-on work with prints, fixtures, engineering files, and TMV setups. There is significant cross-functional collaboration with Quality and Manufacturing in a regulated medical device environment with established documentation and audit protocols.

Job Type & Location

This is a Contract position based out of Louisville, CO.

Pay and Benefits

The pay range for this position is $50.00 - $65.00/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)

Workplace Type

This is a fully onsite position in Louisville,CO.

Application Deadline

This position is anticipated to close on Mar 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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