Biomedical Device Engineer Jobs in Raleigh, NC (NOW HIRING)

Company Description
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide.
We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.
The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.
If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.
Job Description
Primary Function of Position
The Product Development Engineer will lead design and development projects for Intuitive training models. This position requires an extremely motivated and self-driven individual with a high capacity to learn, analyze and address problems in a fast-paced product development environment. It requires a proactive mindset, a strong understanding of the use cases for the models, and collaboration skills to address unmet needs and identify practical, cost-effective design solutions. Joining Intuitive means joining a team dedicated to providing the highest quality and realistic training experience for our customers.
Essential Job Duties
• Lead product development projects for model iterations and design changes for improved user experience, training effectiveness and realism, manufacturability, reliability, and cost. Support new model introduction projects.
• Resolve unmet model needs and engineering challenges through rapid prototyping, design and testing, while collaborating with researchers, product management, scientists, KOL surgeons and engineers.
• Create design documentation including part specifications, drawings, BOMs, test protocols and reports.
• Interface with supplier, manufacturing and quality engineering to prepare for scalable production of the models, definition of new processes, and comply with quality systems.
• Perform root cause investigations for design related issues and design failure mode analyses.
• Document and provide manufacturing process instructions to manufacturing trainer for new and revised models.
• Support successful introductions of new and revised models to the manufacturing line.
• Develop products that meet quality control standards and influence quality control procedures and practices.
• Sustain existing designs to achieve cost targets and maintain component supply continuity.
• Select and test product packaging and work with vendors to convey requirements and select most appropriate design.
Qualifications
Required Skills and Experience
• Minimum 3 years experience in design and product development.
• Knowledge and execution of ISO 9001 quality systems.
• Comfortable working with animal tissue and knowledge of basic anatomy.
• Strong knowledge of surgical/laboratory terminology, equipment, materials, and procedures.
• Demonstrated hands-on problem solving of mechanical engineering challenges.
• Experience with component design and fabrication methods including machining, 3d printing,
laser/die cutting and thermoforming.
• Proficient with CAD models (eg Solidworks) and creating engineering drawings.
• Familiar with all phases of the product development lifecycle, change and design control systems
and processes (eg Agile).
• Ability to work with standard computer applications: SmartSheet, Microsoft Office, Excel,
Outlook, Powerpoint, and Visio.
• Excellent documentation and communication skills. Familiarity with Good Documentation
Practices.
• Strong organizational skills and ability to support multiple fast-paced projects simultaneously.
Required Education and Training

• Minimum Bachelors Degree in Mechanical or Biomedical Engineering or equivalent.

Working Conditions
• Ability to lift at least 40lbs.
Preferred Skills and Experience
• MS degree in an engineering discipline, preferably Mechanical or Biomedical Engineering.
• Experience with SolidWorks and Fusion.
• Prior experience working in an FDA/ISO regulated environment, preferably medical device.
• Experience with fabrication methods including injection molding, hydrogel molding and silicone
molding/casting.
• Experience resolving quality issues from production or assembly. Familiarity with Good
Manufacturing Practices.
• Experience with design of experiments and statistical testing.
• Experience in lean manufacturing, six sigma and standardization techniques.
• Experience with packaging design, selection and vendor management.
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
Mandatory Notices
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee'sstart date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.