Process Engineer, Medical-Device

Actalent Services is hiring a a Process Engineer for a full-time role as part of a key strategic M&A initiative with one of our engineering outsourcing clients in the medical device industry. We are seeking a detail-oriented Process Engineer with a strong medical-device expertise and validation engineering experience. This fully onsite role in Irvine, CA requires an engineering professional who can lead and execute validation activities, remediate documentation, and ensure seamless integration of acquired manufacturing processes and systems.

Responsibilities

• Lead and execute Test Method Validations (TMVs), Measurement System Analyses (MSAs), Equipment Validations (IQ/OQ/PQ), and Process Validations in accordance with FDA and ISO standards.
• Assess and revise Standard Operating Procedures (SOPs), work instructions, and other controlled documents to align with integration requirements.
• Identify gaps in legacy documentation and processes; develop and implement remediation plans to ensure compliance and consistency.
• Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and R&D teams to support integration activities.
• Analyze process and validation data to identify trends, root causes, and opportunities for improvement.
• Support risk assessments and change control processes related to integration and validation activities.
• Ensure all validation deliverables are completed on time and meet regulatory and internal quality standards.

Requirements

• Minimum 5 years of experience in validation engineering within the medical device industry required.
• Prior technical expertise in process engineering and validation, including TMV (Test Method Validation), MSA (Measurement System Analyses), IQ/OQ/PQ, and FDA/ISO standards.
• Bachelor’s degree in Engineering, Life Sciences, or related technical field required.
• Proven expertise in TMV, MSA, equipment and process validation.
• Strong knowledge of FDA regulations, ISO standards, and GMP requirements.
• Proficiency in data analysis and statistical tools.
• Excellent written and verbal communication skills needed for success.
• Ability to work independently in a fast-paced, cross-functional environment.
• Experience with document control systems and electronic quality management systems (eQMS).
• Experience with M&A integration and understanding of post-acquisition process harmonization.
• Prior experience in integrating acquired manufacturing operations.
• Ability to work onsite in Irvine five days per week (Mon-Fri).

Compensation and Benefits Information

• $104,000 - $124,000 Base Salary, 3 Weeks Paid Time-Off, 10 Paid Holidays, eligible for overtime pay

Job Type & Location

This is a Contract position based out of Los Angeles, CA.

Pay and Benefits

The pay range for this position is $50.00 - $60.00/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 Los Angeles,CA.

Application Deadline

This position is anticipated to close on Dec 10, 2025.

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 for other accommodation options.

Salary : $104,000 - $124,000