Process Engineer, Medical Device

Description

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

Requirements

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

Benefits

• Employee Assistance Program
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Critical Illness, Accident, and Hospital
• Transportation benefits
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Irvine,CA. Application Deadline This position is anticipated to close on Dec 23, 2025.
• $104,000 - $124,000 Base Salary, 3 Weeks Paid Time-Off, 10 Paid Holidays, eligible for overtime pay, M/D/V Benefits
• Medical, dental & vision
• Health Spending Account (HSA)
• Short and long-term disability
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Training + Development

Interview process

Visa Sponsorship

Security clearance