Senior R&d Engineer

Job Title: Senior R&D Engineer – Medical Devices

Job Description

The Senior R&D Engineer will drive medical device product development from early concept through commercialization, with a focus on neurovascular devices. This role includes design ownership, cross-functional collaboration, and regulatory support, including hands-on participation in at least one FDA submission. The engineer will contribute to the development of minimally invasive and implantable products that support interventional access and treatment of complex neurovascular diseases.

Responsibilities

• Lead and support product development activities from initial concept and feasibility through design, prototyping, verification and validation, and commercialization.
• Own and contribute to design control documentation, including user needs, requirements, specifications, risk assessments, and design history files.
• Prepare and support regulatory submissions (such as 510(k), MDR, and FDA technical documentation) in collaboration with Regulatory and Quality teams.
• Generate, execute, and review engineering documentation, including test protocols, test procedures, test reports, and technical justifications.
• Perform and document feasibility studies, prototyping activities, and mechanical design iterations to optimize product performance and reliability.
• Support and execute design changes, engineering change orders, and product improvements throughout the product lifecycle.
• Troubleshoot product and process issues in collaboration with Manufacturing, Quality, and Supply Chain teams.
• Support equipment engineering and process transfer activities from development to manufacturing, ensuring robust and scalable processes.
• Contribute to the design and development of test fixtures and test methods for verification, validation, and ongoing product support.
• Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and Supply Chain to ensure compliant and efficient product development in a regulated environment.
• Support post-market changes, remediation projects, and continuous improvement initiatives for existing products.
• Mentor and support junior engineers by providing technical guidance, feedback, and training on design controls, documentation, and best practices.
• Ensure adherence to ISO standards and FDA Quality System Regulations throughout all development activities.

Essential Skills

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 4+ years of R&D or product development experience within the medical device or other regulated industry.
• 5+ years of mechanical engineering experience, including hands-on mechanical design work.
• 4+ years of new product development experience, covering the full lifecycle from concept to commercialization.
• Demonstrated experience supporting product development from initial concept through launch.
• Hands-on experience supporting at least one FDA submission.
• Strong understanding of design controls and regulated product development processes.
• Proficiency with CAD tools, with SolidWorks strongly preferred.
• Proficiency in engineering documentation, including requirements, specifications, test protocols, and reports.
• Experience working cross-functionally in a regulated environment.
• Experience with mechanical design, including design for manufacturability and reliability in medical devices.
• Experience with design changes and change orders in a controlled environment.
• Familiarity with FDA Quality System Regulations and ISO standards relevant to medical devices.

Additional Skills & Qualifications

• Experience with 510(k) submissions is strongly preferred.
• Experience with MDR and FDA technical file or technical documentation is a plus.
• Experience with catheters, minimally invasive devices, or implantable products.
• Prior involvement in verification and validation testing, including protocol development, execution, and reporting.
• Experience supporting post-market changes or remediation projects for medical devices.
• expereince in research and development engineering, product design, and new product introduction.
• Experience with process transfer from R&D to manufacturing and collaboration with equipment engineering.
• Experience developing and using test fixtures and test procedures for mechanical and system-level testing.
• Knowledge of ISO standards and FDA Quality System Regulations applicable to medical device development and manufacturing.
• Degree or coursework in Mechanical, Biomedical, Materials, or related Engineering fields.
• Strong problem-solving skills and the ability to provide clear technical justifications and rationale.
• Ability to mentor and support junior engineers and contribute to a culture of knowledge sharing and continuous learning.

Work Environment

This role operates in a professional engineering and R&D environment focused on the development of novel medical devices for interventional access and treatment of neurovascular diseases. The organization has over 40 years of global leadership in this field and offers one of the most comprehensive product portfolios for treating conditions such as arteriovenous malformations, aneurysms, and ischemic stroke. The work setting combines the close-knit, collaborative feel of a smaller company with the stability, resources, and global reach of a larger organization. Team members work closely with all levels of engineering and cross-functional partners, using modern CAD tools such as SolidWorks and working within robust design control and quality systems aligned with ISO and FDA Quality System Regulations. The culture emphasizes innovation, technical excellence, and patient-focused outcomes, while providing opportunities for professional growth, continuing education, mentorship, and advancement both locally and globally.expereince

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

The pay range for this position is $57.00 - $68.00/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 Irvine,CA.

This position is anticipated to close on May 12, 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.