Mechanical Engineer

Job Description

Job Description

Job Title: Mechanical Engineer

Job Description

This role focuses on full life cycle new product development for medical devices, from initial concept through commercialization. You will design and develop innovative products, lead design validation and verification activities, and support regulatory submissions with robust technical documentation. The position offers the opportunity to work closely with cross-functional teams, contribute to process and equipment engineering, and help bring novel neurovascular technologies to market.

Responsibilities

• Lead and support full life cycle new product development from concept through commercialization for medical devices.
• Perform SolidWorks-based mechanical design, including detailed models, drawings, and assemblies.
• Plan, execute, and document design validation and verification testing to ensure products meet requirements and standards.
• Develop and validate test methods to support product development, verification, and ongoing product performance assessment.
• Conduct design analysis and assessment, including product risk assessment, to ensure safety, reliability, and performance.
• Remediate and update design history and product specifications to align with current requirements and best practices.
• Prepare and maintain technical documentation such as design history files, drawings, bills of materials, test protocols and reports, and engineering change orders.
• Assist in the production of engineering reports that provide clear technical explanations to support domestic and international regulatory submissions.
• Coordinate and lead competitive testing to benchmark products and inform design decisions.
• Support equipment engineering and process transfer activities to move products from development into manufacturing.
• Collaborate with Quality and Regulatory teams to prepare products for FDA and other regulatory submissions.
• Contribute to process development, including validation and verification activities, to ensure robust and repeatable manufacturing processes.
• Participate in research and development initiatives to explore new concepts, technologies, and product improvements.
• Work as an effective team player, presenting design concepts, test results, and technical findings to engineering and cross-functional stakeholders.

Essential Skills

• Bachelor’s degree in Mechanical Engineering, Materials Engineering, Biomedical Engineering, or a related technical field.
• Demonstrated experience in new product development from concept to commercialization, preferably in medical devices.
• Proficiency in SolidWorks for 3D modeling, design, and drafting.
• Experience with design validation and verification testing for complex products.
• expereince in process development, including validation and verification activities.
• Experience with equipment engineering and process transfer from development to production.
• Ability to develop and validate test methods for product and process evaluation.
• Experience in product development engineering within a regulated environment, including familiarity with FDA expectations for medical devices.
• Strong skills in protocol writing, test documentation, and technical reporting.
• Ability to remediate and maintain design history files, product specifications, and related technical documentation.
• Strong analytical and problem-solving abilities for design analysis and product risk assessment.
• Effective communication and presentation skills, with the ability to work collaboratively as a team player.
• Adaptability and willingness to work across multiple engineering disciplines and project phases.

Additional Skills & Qualifications

• Experience supporting domestic and international regulatory submissions for medical devices.
• Familiarity with design history files, bills of materials, engineering change orders, and other controlled documentation systems.
• Exposure to competitive testing and benchmarking of products in a clinical or technical context.
• Background in neurovascular, cardiovascular, or other interventional medical devices.
• Interest in continuing education and professional development through mentorship and training opportunities.
• Comfort working in a setting that offers access and exposure to all levels of engineering and leadership.

Work Environment

This role is based within a global organization that has specialized for over 40 years in the innovation of novel products for the interventional access and treatment of neurovascular diseases. The company offers one of the most comprehensive product portfolios in the field, with products used worldwide to access and treat conditions such as arteriovenous malformations, aneurysms, and ischemic stroke. You will work in a collaborative engineering environment with access and involvement at all levels of the engineering organization, benefiting from a smaller company feel with the support and stability of a larger corporate backing. The culture emphasizes innovation, growth opportunities locally and globally, continuing education, and mentorship. You can expect to work with modern engineering tools such as SolidWorks and structured documentation systems while collaborating closely with Quality, Regulatory, and R&D teams in a professional, development-focused setting.

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.

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 Jun 30, 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 actalentaccommodation@actalentservices.com 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.