R&D Engineer
Actalent, Irvine, CA, United States
R&D Engineer
Lead full‑cycle new product development from initial concept through commercialization for innovative medical devices used in the treatment of neurovascular diseases. Design and analyze products using SolidWorks, develop and validate test methods, and execute design verification and validation activities. Prepare comprehensive technical documentation to support domestic and international regulatory submissions and collaborate closely with Quality and Regulatory teams to prepare products for FDA review. Contribute to product risk assessments and competitive testing to inform strategic decisions.
Responsibilities
Lead full‑cycle new product development from concept through commercialization.
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 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.
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 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.
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 work environment combines a smaller company feel with the stability and resources of a larger organization, offering 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
Contract position based out of Irvine, CA.
Pay And Benefits
The pay range for this position is $36.00 - $40.00/hr.
Benefits
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
Fully onsite position in Irvine, CA.
Application Deadline
This position is anticipated to close on May 1, 2026.
Actalent is an equal opportunity employer.
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Lead full‑cycle new product development from initial concept through commercialization for innovative medical devices used in the treatment of neurovascular diseases. Design and analyze products using SolidWorks, develop and validate test methods, and execute design verification and validation activities. Prepare comprehensive technical documentation to support domestic and international regulatory submissions and collaborate closely with Quality and Regulatory teams to prepare products for FDA review. Contribute to product risk assessments and competitive testing to inform strategic decisions.
Responsibilities
Lead full‑cycle new product development from concept through commercialization.
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 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.
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 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.
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 work environment combines a smaller company feel with the stability and resources of a larger organization, offering 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
Contract position based out of Irvine, CA.
Pay And Benefits
The pay range for this position is $36.00 - $40.00/hr.
Benefits
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
Fully onsite position in Irvine, CA.
Application Deadline
This position is anticipated to close on May 1, 2026.
Actalent is an equal opportunity employer.
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