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Lead Quality Assurance Engineer for Sterilization Processes
2 months ago
At Intuitive Surgical, we are driven by our mission to enhance lives through minimally invasive care. Our innovative technology empowers healthcare professionals to provide exceptional care without limitations.
As a leader in robotic-assisted surgery, we are dedicated to cultivating a diverse and inclusive workforce that is passionate about making a positive impact in healthcare.
With over 25 years of experience, we collaborate with healthcare providers globally to tackle some of the most challenging issues in the industry and push the boundaries of what is achievable.
We value contributions from individuals with diverse backgrounds and believe that great ideas can emerge from anywhere. Our inclusive culture is built on respect and the diversity of thought, enabling our team members to perform at their best as their authentic selves.
Our culture is fueled by passionate individuals who strive to make a difference. Our team members exemplify integrity, possess a strong learning capacity, and bring a wealth of real-world experiences that inspire innovative thinking.
We are committed to investing in our team members' long-term growth, empowering them to advance our mission and reach their fullest potential.
Position Overview:
The Senior Quality Engineer plays a pivotal role in the validation of cleaning, disinfection, and sterilization processes for reusable medical devices used in robotic-assisted surgery and minimally invasive procedures.
This position requires collaboration with cross-functional teams to provide essential design insights that facilitate effective cleaning and sterilization of new medical devices.
The Senior Quality Engineer will be responsible for conducting validation testing for cleaning and sterilization, either on-site or in partnership with external laboratories, to support regulatory submissions both domestically and internationally.
A comprehensive understanding of relevant domestic and international standards for reprocessing is essential for this role.
Key Responsibilities:
- Lead multiple validation studies focusing on cleaning, disinfection, and sterilization, ensuring the safety and efficacy of new robotic medical devices.
- Manage concurrent projects, maintaining effective communication and collaboration with internal departments and external partners.
- Define testing strategies and plans to ensure the safety and efficacy of new products across the company's platforms.
- Work closely with Regulatory Affairs to facilitate compliance with regulatory submissions and approvals.
- Develop and uphold procedures and best practices to ensure adherence to applicable cleaning and sterilization standards.
- Enhance cleaning and sterilization processes and systems for optimal efficiency.
- Assist in creating harmonized reprocessing manuals for end users, simplifying reprocessing tasks while ensuring compliance with industry standards.
- Possess a solid understanding of medical device industry standards related to reprocessing.
- Conduct field visits to customer sites to recommend improvements for reprocessing workflows.
- Engage in industry working groups to contribute to the development of new standards.
- Perform additional duties as assigned.
Qualifications:
To effectively fulfill the responsibilities of this position, candidates should possess:
- A Bachelor’s degree in Engineering, Life Sciences, Microbiology, or a related technical field; a Master’s degree is preferred.
- A minimum of 8 years of experience in the medical device industry, including at least 3 years focused on cleaning and sterilization validation.
- Familiarity with relevant medical device cleaning and sterilization standards.
- Strong verbal and written communication skills, with the ability to collaborate across various teams.
- Self-motivated with the capability to thrive in a fast-paced environment.
- Proven ability to manage multiple projects and prioritize effectively.
- Hands-on experience in a cross-functional team setting.
- Attention to detail and adaptability to support diverse projects.
- Proficiency in MS Office Suite, including statistical analysis tools.
- Willingness to travel to customer or laboratory sites as needed.
Additional Information:
Intuitive Surgical is an Equal Employment Opportunity Employer, committed to providing equal opportunities to all qualified applicants and employees. We prohibit discrimination and harassment of any kind, ensuring a respectful workplace for all.
