Job Details

Job Description

Job Title: Manufacturing Engineer

Job Description

This Manufacturing Engineer role focuses on process and retrospective validations, quality-driven manufacturing support, and MDR remediation efforts within a regulated medical device environment. You will apply a strong ISO-based quality mindset, execute rigorous validation activities, and maintain high standards of documentation to ensure compliant, efficient, and continuously improving manufacturing processes.

Responsibilities

• Execute process validations, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and retrospective validations for existing processes.
• Support MDR remediation activities by reviewing, updating, and maintaining all related documentation to align with current regulatory expectations.
• Perform statistical data analysis to support validation activities, assess process capability, and identify opportunities for continuous improvement.
• Author, review, and execute validation protocols and reports, ensuring they meet internal standards and regulatory requirements.
• Update and maintain Work Instructions (WIs), Standard Operating Procedures (SOPs), and other manufacturing documentation to reflect current practices and improvements.
• 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 manufacturing processes comply with applicable medical device regulations and quality system requirements.
• Ensure manufacturing processes meet ISO-based and internal quality standards, and drive adherence to best practices in quality and compliance.
• Support internal and external audits and inspections by providing documentation, explaining processes, and addressing findings related to validation and manufacturing.
• Contribute to cost reduction initiatives by analyzing processes, identifying efficiencies, and implementing validated improvements.
• Drive and support continuous improvement and lean manufacturing activities across manufacturing processes.
• Prepare clear, concise technical reports and documentation to communicate validation outcomes, process changes, and improvement results.
• Participate in cross-functional projects related to process development, process improvement, and manufacturing engineering.

Essential Skills

• 1–4 years of engineering experience in a regulated manufacturing environment.
• Medical device manufacturing experience.
• Working knowledge of ISO-based standards and medical device quality systems.
• Experience with process validation, including IQ/OQ/PQ and retrospective validations.
• Strong understanding of quality principles in a regulated environment.
• Bachelor's degree in Engineering, Manufacturing, Production, or a related science discipline.
• Strong technical writing and documentation skills, including authoring validation protocols, reports, and manufacturing documentation.
• Hands-on experience with process validation and manufacturing documentation.
• Ability to perform statistical data analysis for validation and process capability assessments.
• Experience updating Work Instructions (WIs), SOPs, and production records.
• Demonstrated ability to support MDR remediation activities or similar regulatory-driven documentation updates.
• Proven capability to collaborate with cross-functional teams in Quality, Manufacturing, and Engineering.

Additional Skills & Qualifications

• Experience supporting MDR remediation projects in a medical device environment.
• Familiarity with FDA medical device regulations and broader medical device regulatory expectations.
• Experience working in a high-volume or precision manufacturing environment.
• in validation data analysis and process improvement initiatives.
• Experience with cost reduction projects in manufacturing.
• Strong report writing and general writing skills for clear technical communication.
• Continuous improvement mindset with experience applying lean manufacturing principles.
• Knowledge of Six Sigma methodologies and tools.
• Experience in manufacturing process development and process improvement.
• Exposure to SolidWorks or similar engineering design tools.
• Experience with machining, assembly, automation, and production environments.
• Project management skills for coordinating validation and improvement activities.
• Broad experience in manufacturing engineering and validation within regulated industries.

Work Environment

The role operates within a regulated medical device manufacturing environment that emphasizes rigorous quality standards, robust documentation, and compliance with ISO-based quality systems and medical device regulations. You will work closely with cross-functional teams in Quality, Manufacturing, and Engineering, often in a production setting that may be high-volume or precision-focused. The environment supports structured validation activities, continuous improvement initiatives, lean manufacturing practices, and data-driven decision-making. You can expect frequent interaction with manufacturing documentation systems, validation tools, and engineering software, as well as participation in audits and inspections to maintain a compliant and efficient operation.Experi

This is a Contract position based out of Carpinteria, CA.

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)

This is a fully onsite position in Carpinteria,CA.

This position is anticipated to close on Jun 4, 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.