Job Title: Manufacturing Process Engineer
Job Description
The Manufacturing Process Engineer will focus on process and retrospective validations, quality-driven manufacturing support, and MDR remediation initiatives within a regulated medical device environment. The role requires hands-on experience with medical device manufacturing, a strong ISO-based quality mindset, and the ability to work within rigorous validation, documentation, and continuous improvement standards.
Responsibilities
Execute process validations, including IQ, OQ, PQ, and retrospective validations, to ensure robust and compliant manufacturing processes.
Support MDR remediation activities by updating related documentation, records, and validation packages as required.
Perform statistical data analysis to support validation activities, assess process capability, and drive continuous improvement.
Author, review, and execute validation protocols and validation reports in accordance with internal procedures and regulatory expectations.
Update and maintain Work Instructions (WIs), Standard Operating Procedures (SOPs), and other manufacturing documentation to reflect current processes and best practices.
Create, update, and maintain Device Master Records (DMRs) to ensure accurate and complete product and process documentation.
Collaborate closely with Quality, Manufacturing, and Engineering teams to ensure compliance with applicable medical device regulations and internal quality systems.
Ensure manufacturing processes consistently meet ISO requirements and internal quality standards.
Support internal and external audits and inspections by providing documentation, data, and technical explanations related to processes and validations.
Identify and implement cost reduction opportunities while maintaining product quality and regulatory compliance.
Contribute to process development and process improvement initiatives across manufacturing operations.
Apply lean manufacturing and continuous improvement principles to enhance efficiency, reduce waste, and improve process reliability.
Support production, machining, assembly, and automation activities from a process engineering and validation perspective.
Prepare clear, accurate, and well-structured technical reports and documentation to communicate findings, results, and recommendations.
Participate in cross-functional projects and apply project management skills to deliver validation and process improvement activities on time.
Essential Skills
1-4 years of engineering experience in a regulated manufacturing environment.
Hands-on medical device manufacturing experience.
Working knowledge of ISO-based quality systems and medical device quality requirements.
Demonstrated experience with process validation, including IQ/OQ/PQ and retrospective validations.
Experience with manufacturing documentation, including Work Instructions (WIs), SOPs, and Device Master Records (DMRs).
Strong understanding of quality principles in a regulated environment.
Proficiency in statistical data analysis to support validation and process capability assessments.
Strong technical writing and documentation skills, including validation protocols, reports, and technical summaries.
Ability to support MDR remediation projects and associated documentation updates.
Bachelor's degree in Engineering, Manufacturing, Production, or a related science discipline.
Additional Skills & Qualifications
Experience supporting MDR remediation projects in a medical device @context.
Familiarity with FDA medical device regulations and medical device regulatory expectations.
Experience working in a high-volume or precision manufacturing environment.
Experience in validation data analysis and process improvement initiatives.
Experience in cost reduction and efficiency improvement within manufacturing processes.
Knowledge of lean manufacturing and continuous improvement methodologies.
Exposure to Six Sigma tools and approaches for process improvement.
Experience with manufacturing processes such as machining, assembly, automation, and production support.
Experience in manufacturing engineering and process development in a regulated setting.
Proficiency with SolidWorks or similar engineering design tools is beneficial.
Strong general engineering and problem-solving skills.
Ability to manage projects, prioritize tasks, and meet deadlines in a dynamic environment.
Effective communication and collaboration skills when working with cross-functional teams.
Work Environment
The role operates within a regulated medical device manufacturing environment that emphasizes high quality standards, robust documentation, and compliance with ISO and medical device regulations. The engineer will work closely with Quality, Manufacturing, and Engineering teams in a setting that may include high-volume and precision manufacturing operations, machining, assembly, automation, and production lines. The position involves frequent interaction with validation and quality documentation systems, statistical analysis tools, and engineering software such as SolidWorks. Work is typically performed during standard business hours, with additional effort as needed to support validations, audits, and project deadlines. The environment promotes continuous improvement, lean manufacturing practices, and cross-functional collaboration to enhance process reliability, efficiency, and product quality.Experience
Job Type & Location
This is a Contract position based out of Carpinteria, CA.
Pay and Benefits
The pay range for this position is $40.00 - $45.00/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 Carpinteria,CA.
Application Deadline
This position is anticipated to close on May 16, 2026.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC-with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.
Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.
