Principal Manufacturing Engineer

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
Be responsible for overseeing and optimizing our manufacturing processes to ensure efficiency, quality, and cost-effectiveness.  The person in this position will be a technical leader that is expected to mentor other manufacturing engineers within the larger team as well as train others in cross-functional teams to ensure seamless transition of new products to manufacturing.

Essential Job Duties

• Develop and implement manufacturing strategies and processes to improve productivity and enhance product quality.
• Mentor teams of manufacturing engineers, providing guidance and support to ensure successful execution of projects.
• Collaborate with cross-functional teams, including design, production, and quality assurance, to ensure seamless integration of manufacturing processes.
• Conduct feasibility studies and cost analysis to determine the most efficient manufacturing methods and equipment.
• Identify and implement process improvements, including lean manufacturing techniques, to optimize production efficiency and reduce scrap.
• Work closely with and inform the automation and equipment team requirements needed for future manufacturing line designs.
• Develop and maintain manufacturing documentation, including work instructions, standard operating procedures, and quality control plans.
• Monitor and analyze production data to identify trends, troubleshoot issues, and implement corrective actions.
• Stay updated with industry trends and advancements in manufacturing technology, and recommend innovative solutions to enhance our manufacturing capabilities.
• Ensure compliance with regulatory requirements and industry standards, such as ISO and FDA regulations.
• Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes.
• Lead effort in development and optimization of process validations (IQ/OQ/PQ)
• Focus on continuous improvement efforts; able to evaluate, prioritize and drive implementation of those efforts

Qualifications

Required Skills and Experience 

• Technical expertise in Design Controls, process validations, Gage R&R and requirements traceability
• Technical expertise in the development of proper process FMEAs
• Technical expertise and support to resolve complex manufacturing issues
• Strong knowledge of FDA/ISO regulatory requirements and quality management systems.
• Excellent leadership and team management skills.
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills.
• Ability to work collaboratively in a fast-paced, high-pressure and cross-functional team environment.
• Ability to demonstrate oneself to senior management as an expert who will influence changes, implementation strategies, etc.
• Ability to evaluate and develop new technology, tools and processes that improve the overall business

Required Education and Training 

• Bachelor's degree in Engineering or a related field.
• Minimum of ten (10) years of experience in medical device manufacturing with BS or, six (6) years of experience with MS or PhD degree.
• Proven experience as a Manufacturing Engineer and leade