Mechanical Engineer, Product Engineering, Disposables

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Primary Function of Position:

Accessories serve as the interface between other aspects of the da Vinci system and enable safe and effective robot-assisted surgery. They may be reusable or single-use medical devices (consumables), with yearly volumes in the millions. Our customers interact directly with accessories in every surgical procedure, and they serve a critical role in customer satisfaction and patient outcomes.

The Product Engineer will help support performance, cost, capacity and reliability improvements for Intuitive’s surgical accessories, and complete the development, documentation, and verification of these improvements.   The successful candidate will thrive in a fast-paced environment and have a passion for continuous improvement, and the ability to bring a cross functional team together to solve problems.  A strong sense of responsibility and project ownership is required as well as a commitment to high product quality.

Roles and Responsibilities:

• Work in cross-functional project teams to design, develop and verify modifications to surgical accessories.
• Support supplier change requests and variance requests, reviewing qualification plans to ensure conformance to product requirements
• Research historical requirements and theory of operation to evaluate proposed product changes.
• Develop and maintain Design History Files per FDA requirements.
• Support investigations to determine root cause and assess risks of both latent and emerging design, manufacturing, or material defects.
• Develop, implement, test and document solutions for these defects according to corporate standard and departmental operating procedures.
• Create and maintain engineering drawings and documentation in accordance to stringent Design Control activities.
• Identify solutions that meet both customer and business needs. 
• Support design changes, alternate material qualification, improve manufacturability, capacity, operational efficiency.
• Support the CAPA processes and quality/regulatory audits as required.
• Complete individual goals consistent with overall project goals 

Qualifications

Skill/Job Requirements:

• Minimum BSME required, MSME preferred.  Minimum 5 years of experience in relevant engineering field (Prior medical device experience preferred)
• Self-driven with the ability to excel in a high-energy, small, focused team environment, to maintain a strong sense of shared responsibility and reward, and to make work fun and interesting.
• Ability to communicate effectively and accurately (written and oral) across all levels and functions, including presenting to a technical audience.
• Mechanical design and analysis skills, including statics, dynamics, kinematics, strength of materials and stress analysis. 
• Exposure to product development lifecycle including design, implementation, debug, verification, qualification, and transfer to manufacturing.
• Experience with concepts of design input, design output, traceability, and risk analysis
• Experience using CAD to design and document mechanisms; SolidWorks preferred.
• Experience designing plastic components and assemblies.
• Knowledge of component manufacturing processes (including injection molding, extrusion, thermoset mo