R&D Engineer

Job Title: R&D Engineer Job Description
The R&D Engineer supports product transfer projects for catheter and coil-based medical devices into a medical device manufacturing facility and contributes to full-cycle new product development from concept through commercialization. This role serves as the R&D representative on cross-functional teams, leads design activities using SolidWorks, and ensures that products, processes, and documentation meet stringent quality, regulatory, and performance requirements.
Responsibilities
- Serve as the R&D representative on cross-functional product transfer teams, collaborating closely with Manufacturing, Quality, Regulatory, and Supply Chain to ensure successful transfers.
- Support product transfer projects for catheter and coil-based medical devices transitioning into the manufacturing facility.
- Create, update, revise, and release detailed engineering drawings utilizing SolidWorks in accordance with internal standards and quality system requirements.
- Maintain design documentation and engineering records, ensuring compliance with applicable quality system and regulatory requirements.
- Assist in evaluating manufacturing processes, equipment, tooling, fixtures, and materials for transferred products to ensure robust and efficient production.
- Coordinate and support verification, validation, and product testing activities for both transferred and new products.
- Analyze engineering data, interpret test results, and document findings to support design and process decisions.
- Ensure transferred products continue to meet design requirements, performance expectations, and risk management standards.
- Participate in continuous improvement activities related to products and manufacturing processes, identifying opportunities to enhance quality, efficiency, and reliability.
- Support multiple product transfer projects simultaneously, adjusting priorities as business needs evolve.
- Contribute to full-cycle new product development from concept to commercialization, including design, prototyping, and design transfer.
- Plan, execute, and document design validation and verification testing, including test method development and refinement.
- Develop and validate test methods to ensure reliable, repeatable, and compliant product testing.
- Remediate design history and product specifications as needed to align with current standards and regulatory expectations.
- Perform design analysis and assessment to evaluate product performance, risks, and design robustness.
- Assist in the production of engineering reports that provide clear technical explanations to support domestic and international regulatory submissions.
- Prepare technical documentation including design history files, drawings, bills of materials, test protocols and reports, engineering change orders, and related records.
- Coordinate and lead competitive testing to benchmark products against market alternatives and inform design and development decisions.
- Conduct product development and product risk assessment activities in collaboration with cross-functional stakeholders.
- Work with Quality and Regulatory teams to prepare products for FDA submission and other regulatory approvals.
Essential Skills
- Bachelors degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering, or a related technical field.
- Proficiency in SolidWorks for creating and managing engineering drawings and models.
- Experience with new product development, preferably within medical device manufacturing or research and development.
- Exposure to validation and verification activities, including protocol writing and test execution.
- Understanding of product transfer, process transfer, and design transfer within a regulated manufacturing environment.
- Familiarity with FDA expectations and test methods relevant to medical device development.
- Ability to develop and validate test methods and interpret engineering test data.
- Strong skills in design analysis, assessment, and product risk evaluation.
- Experience preparing technical documentation such as design history files, bills of materials, test protocols and reports, and engineering change orders.
- Capability to assist with engineering reports and technical documentation to support regulatory submissions.
- Team-oriented mindset with the ability to collaborate effectively across engineering, quality, regulatory, and manufacturing functions.
- Adaptability and the ability to present technical information clearly to various stakeholders.
Additional Skills & Qualifications
- Project or internship experience within medical device manufacturing, research and development, or product development engineering.
- Experience with equipment engineering and transfer for medical device production.
- Background in design validation and verification testing for medical devices.
- Knowledge of test method development and refinement in a regulated environment.
- Experience coordinating and leading competitive testing initiatives.
- Familiarity with product risk assessment methodologies and tools.
- Experience working with Quality and Regulatory teams to prepare products for FDA submission and other global regulatory pathways.
- Interest in continuing education and professional development, supported by mentorship and learning opportunities.
Work Environment
This role is based in a medical device manufacturing facility focused on innovative catheter and coil-based products for the interventional access and treatment of neurovascular diseases. The environment offers access and involvement with all levels of engineering and departments, providing a smaller company feel with the stability and resources of a larger organization. Team members work with advanced design tools such as SolidWorks and collaborate closely with Manufacturing, Quality, Regulatory, and Supply Chain functions. The culture emphasizes innovation, continuous improvement, mentorship, and global growth opportunities, with a comprehensive portfolio of products used worldwide to treat complex neurovascular conditions.
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. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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 Oct 7, 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 [email protected] 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
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