R&D Engineer

Job Title: R&D Engineer

Job Description

The R&D Engineer leads full-cycle new product development from initial concept through commercialization for innovative medical devices used in the treatment of neurovascular diseases. This role designs and analyzes products using SolidWorks, develops and validates test methods, and executes design verification and validation activities. The engineer prepares comprehensive technical documentation to support domestic and international regulatory submissions, collaborates closely with Quality and Regulatory teams to prepare products for FDA review, and contributes to product risk assessments and competitive testing. This position offers the opportunity to work on cutting-edge technologies within a collaborative environment that supports professional growth, continuing education, and mentorship.

Responsibilities

Lead full-cycle new product development from concept through commercialization for medical devices.
Perform design validation and verification testing to ensure products meet performance and regulatory requirements.
Create and refine 3D models and engineering drawings using SolidWorks.
Execute equipment engineering activities and support equipment and process transfer into manufacturing.
Develop and validate test methods to ensure robust, repeatable, and compliant testing of products and processes.
Remediate and update design history and product specifications to align with current standards and regulatory expectations.
Conduct design analysis and assessment to optimize product performance, reliability, and safety.
Assist in the production of detailed engineering reports that provide technical explanations to support domestic and international regulatory submissions.
Prepare comprehensive technical documentation, including design history files, drawings, bills of materials, test protocols and reports, and engineering change orders.
Coordinate and lead competitive testing to benchmark products and inform design improvements and strategic decisions.
Contribute to product development planning and product risk assessment activities.
Work closely with Quality and Regulatory teams to prepare products and documentation for FDA and other regulatory reviews.
Collaborate with cross-functional engineering teams and effectively present technical information to stakeholders.
Participate in process development and process transfer activities to ensure smooth scale-up from R&D to production.
Support research and development initiatives related to medical devices and new technologies.

Essential Skills

Experience in full-cycle new product development from concept to commercialization, preferably in medical devices.
Proficiency in SolidWorks for 3D modeling and engineering drawing creation.
Hands-on experience with design validation and verification testing.
Experience in equipment engineering and process transfer to manufacturing.
Ability to develop and validate test methods for products and processes.
Knowledge of design history file remediation and product specification updates.
Strong skills in design analysis and assessment for performance, reliability, and safety.
Experience in writing and executing test protocols and generating test reports.
Understanding of product development engineering within a regulated environment, including FDA considerations.
Ability to prepare and maintain technical documentation such as drawings, bills of materials, and engineering change orders.
Strong written and verbal communication skills to assist in engineering reports and regulatory support documentation.
Ability to work effectively as a team player, adapt to changing priorities, and present technical information clearly.

Additional Skills & Qualifications

Bachelor’s degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering, or a related technical field.
Experience in medical device research and development.
Experience in process development for medical devices or other regulated products.
Familiarity with product risk assessment methodologies.
Experience coordinating or leading competitive testing activities.
Exposure to domestic and international regulatory submission processes.
Interest in continuing education and openness to mentorship and professional development opportunities.
Comfort working with and presenting to various levels of engineering and cross-functional stakeholders.

Work Environment

This role supports the development of novel products for the interventional access and treatment of neurovascular diseases within a company that has been a global leader in this field for over 40 years. The organization offers one of the most comprehensive product portfolios for treating conditions such as arteriovenous malformations, aneurysms, and ischemic stroke, and its products are used worldwide. The work environment combines a smaller company feel with the stability and resources of a larger organization, providing direct access and involvement with all levels of engineering. Team members benefit from growth opportunities locally and globally, as well as continuing education and mentorship. The setting is a professional engineering and R&D environment focused on innovation, collaboration, and high-quality medical device development.

Job Type & Location

This is a Contract to Hire position based out of Irvine, CA.

Pay And Benefits

The pay range for this position is $36.00 - $40.00/hr.

Requirements

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 Irvine,CA.

Application Deadline

This position is anticipated to close on May 13, 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.
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