Job Information
Actalent Senior Mechanical Engineer in Irvine, California
Senior Engineer, Verification & Validation
Acute Care Technology
About the Company
This organization is a global leader in acute care and lifesaving medical technologies, dedicated to improving patient outcomes in critical and emergency care settings. With a strong focus on innovation, quality, and patient safety, the company develops advanced medical solutions used by clinicians and first responders worldwide. Its culture emphasizes collaboration, scientific rigor, and a shared mission to deliver reliable, high‑performance medical devices that make a meaningful difference when it matters most.
Position Summary
As a Senior Engineer, you will lead verification and validation (V&V) activities for Class II disposable medical devices, supporting products from early proof‑of‑concept through global commercialization. You will be responsible for developing and executing test strategies, authoring protocols and reports, training technicians, and performing hands‑on testing. This role is highly cross‑functional and integral to product development, quality, regulatory compliance, and risk management throughout the product lifecycle.
We are seeking a creative, analytical engineer who approaches problem solving with logic, curiosity, and discipline—someone who thrives in regulated environments and enjoys contributing directly to patient‑impacting technologies.
Key Responsibilities
Interpret product and system requirements and develop verification methods and acceptance criteria to demonstrate compliance.
Author, execute, and document verification and validation protocols and reports using appropriate statistical tools and methodologies.
Design, execute, and analyze experiments, including the application of Design of Experiments (DOE) and statistical techniques.
Analyze, summarize, and clearly communicate test data and results to technical and non‑technical stakeholders.
Contribute to product risk management activities, including FMEA, Fault Tree Analysis (FTA), and System Hazard Analysis (SHA).
Train and guide technicians in test methods, equipment use, and proper documentation practices.
Participate in periodic design reviews, providing technical input and risk‑based assessments.
Collaborate closely with engineering, quality, regulatory, operations, and external partners in a matrixed development environment.
What You’ll Have the Opportunity to Do
Directly contribute to improving and saving patient lives.
Make a meaningful impact on both short‑term product success and long‑term technology strategy.
Work closely with Senior leadership and cross‑functional teams across the organization.
Grow and shape your role based on your strengths, interests, and career goals.
Gain deep exposure to respiratory medical device manufacturing and lifecycle management.
Help create an inspiring, collaborative, and high‑performance workplace culture.
Required Qualifications
4–6 years of relevant engineering experience, preferably in medical device development or another highly regulated industry.
Strong experience with regulated product development environments, including ISO requirements, GMP/GDP guidelines, FDA regulations, international regulations, and design controls.
Working knowledge of international medical device standards, including ISO 13485, ISO 14971, and IEC 60601 and related collateral standards.
Proven ability to work effectively in a cross‑functional, matrixed organization.
Ability to work independently, solve complex technical problems, and coordinate with internal and external teams to procure materials and services.
Collaborative, results‑oriented mindset with a strong sense of ownership and accountability.
Proficiency in SolidWorks for 3D design and development, including the ability to create, interpret, and apply 2D engineering drawings and specifications.
Education
- Bachelor of Science in Mechanical Engineering, Plastics Engineering, Biomedical Engineering, or a related technical discipline (or equivalent).
Job Type & Location
This is a Contract position based out of Irvine, CA.
Pay and Benefits
The pay range for this position is $65.00 - $85.00/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)
Workplace Type
This is a fully onsite position in Irvine,CA.
Application Deadline
This position is anticipated to close on Apr 29, 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.