R&D Engineer

Job Title: R&D Engineer

Job Description

The R&D Engineer supports the transfer and development of catheter and coil-based medical devices, ensuring products move smoothly into the manufacturing facility while maintaining high quality and regulatory standards. This role serves as the R&D representative on cross-functional teams, driving full-cycle new product development from concept through commercialization, and leading design validation and verification activities. The engineer creates and maintains SolidWorks designs and design documentation, collaborates closely with Manufacturing, Quality, Regulatory, and Supply Chain, and helps ensure that all transferred products meet design requirements and performance expectations.

Responsibilities

• Serve as the R&D representative on cross-functional product transfer teams, collaborating with Manufacturing, Quality, Regulatory, and Supply Chain to ensure successful transfers of catheter and coil-based medical devices to the facility.

• Support product transfer projects by evaluating manufacturing processes, equipment, tooling, fixtures, and materials for transferred products and recommending improvements where needed.

• Create, update, revise, and release engineering drawings and models using SolidWorks, ensuring accuracy and alignment with design intent.

• Maintain design documentation and engineering records in accordance with the companys quality system requirements, including proper version control and traceability.

• Coordinate and support verification, validation, and product testing activities, including design validation and verification testing for new and transferred products.

• Analyze engineering data, test results, and process information, and document findings to support design decisions, process changes, and continuous improvement initiatives.

• Ensure transferred products continue to meet design requirements, performance expectations, and risk management criteria throughout their lifecycle.

• Participate in continuous improvement activities related to products and manufacturing processes, contributing to improved efficiency, quality, and reliability.

• Support multiple product transfer and development projects simultaneously, prioritizing tasks and adapting to evolving business needs.

• Contribute to full cycle new product development from concept to commercialization, including design, prototyping, testing, and design transfer to manufacturing.

• Develop and validate test methods for product and process verification, ensuring methods are robust, repeatable, and compliant with applicable standards.

• Remediate design history files and product specifications to align with current regulatory and quality requirements, and close documentation gaps.

• Perform design analysis and assessment to evaluate product performance, risks, and compliance with requirements, and recommend design improvements.

• Assist in the production of engineering reports that provide 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 activities to benchmark product performance against alternative solutions and inform design and marketing strategies.

• Support product development and product risk assessment activities, working with cross-functional teams to identify, analyze, and mitigate product risks.

• Collaborate with Quality and Regulatory teams to prepare products for FDA submission and other regulatory approvals, ensuring technical documentation is complete and accurate.

• Support equipment engineering and transfer activities, helping to qualify and transition equipment needed for manufacturing transferred products.

Essential Skills

• Bachelors degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering, or a related technical field.

• Proficiency in SolidWorks for creating and managing 3D models and engineering drawings.

• Experience or strong project/internship in medical device manufacturing or medical device research and development.

• Hands-on involvement in new product development, including concept generation, design, and design transfer to manufacturing.

• Experience with validation and verification activities, including protocol writing, test execution, and documentation of results.

• Understanding of product transfer, process transfer, and design transfer within a regulated manufacturing environment.

• Knowledge of FDA requirements and test methods relevant to medical device development and submission.

• Ability to develop and validate test methods for product and process verification.

• Capability to remediate design history files and product specifications to meet quality and regulatory expectations.

• Skills in design analysis and assessment, including evaluation of product performance, risk, and compliance.

• Ability to prepare technical documentation such as design history files, drawings, bills of materials, test protocols and reports, and engineering change orders.

• Experience coordinating or leading competitive testing to benchmark product performance.

• Ability to support product risk assessment and collaborate on risk mitigation strategies.

• Experience working with Quality and Regulatory teams to prepare products for FDA and other regulatory submissions.

• Strong team player who is adaptable and able to present technical information clearly to various stakeholders.

Additional Skills & Qualifications

• Project or internship experience in product development engineering within a medical device environment.

• Exposure to test method development and optimization for medical devices.

• Experience with equipment engineering and transfer in a manufacturing setting.

• Familiarity with process development and process transfer for medical devices.

• Ability to coordinate cross-functional activities and manage multiple projects concurrently.

• Strong documentation skills and attention to detail in preparing engineering reports and technical files.

• Interest in continuing education and professional development within medical device R&D.

• Comfort working in a smaller company environment with broad access to different engineering disciplines and departments.

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 a smaller company feel with the backing and resources of a larger organization, providing access and involvement with all levels of engineering and departments. The company culture emphasizes innovation, collaboration, and continuous learning, with growth opportunities locally and globally, as well as continuing education and mentorship. Work is performed in a regulated setting that adheres to medical device quality systems and FDA-related requirements, with close interaction between R&D, Manufacturing, Quality, Regulatory, and Supply Chain teams.

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 9, 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 acknowledge and agree that your application may be reviewed using AI tools.