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Lead Quality Assurance Engineer, Sterilization Processes
2 months ago
At Intuitive Surgical, we are dedicated to our mission: we believe that minimally invasive care is transformative. Through innovation and advanced technology, we enhance the capabilities of healthcare professionals to provide care without limitations.
As a leader in robotic-assisted surgery, we are committed to cultivating a diverse and inclusive workforce, focused on making a significant impact in the healthcare sector.
For over 25 years, we have collaborated with healthcare facilities and teams globally to tackle some of the most challenging issues in healthcare and expand the boundaries of what is achievable.
Intuitive Surgical thrives on the contributions of talented individuals from various backgrounds. We believe that exceptional ideas can emerge from anywhere. Our culture promotes inclusivity, diversity of thought, and mutual respect. We prioritize inclusion and empower our employees to perform at their best as their authentic selves.Our culture is driven by passionate individuals who aspire to make a difference.
Our team members embody integrity, possess a strong capacity for learning, exhibit the energy to accomplish tasks, and bring diverse, real-world experiences that encourage innovative thinking.
We actively invest in our employees to support their long-term development, enabling them to further our mission and reach their fullest potential.
Position Overview:The Senior Validation Engineer plays a pivotal role as a key resource within the organization for the cleaning, disinfection, and sterilization testing and validation of reusable medical devices.
This individual will collaborate with cross-functional teams to provide design insights that facilitate effective cleaning, disinfection, and sterilization of innovative reusable medical devices.
The Senior Validation Engineer will execute validation testing for cleaning, disinfection, and sterilization either on-site or in partnership with external laboratories to support regulatory submissions both domestically and internationally.
This role requires a solid understanding of relevant domestic and international standards related to reprocessing.Additionally, this position may involve engaging with end-users to comprehend central reprocessing protocols, enhance workflows, and refine usage instructions.
The ideal candidate will thrive in a dynamic, high-energy environment, working alongside multidisciplinary teams to drive solutions from initial design specifications to product launch and ongoing support.
A strong commitment to product quality and the ability to learn swiftly and devise innovative solutions are essential for success in this role.
It is crucial to foster a sense of shared responsibility and reward, while also ensuring that the work environment remains engaging and enjoyable.
Key Responsibilities:- Lead multiple validation and verification studies focusing on cleaning, disinfection, and sterilization, emphasizing the safety and efficacy of new robotic medical devices.
- Simultaneously manage various projects requiring regular communication and collaboration with internal departments and external service providers (vendors and laboratories).
- Establish reprocessing testing strategies and plans to guarantee safety and efficacy for new instruments and accessory products across the company's platforms. Provide expert input on design, materials, and product specifications to optimize reprocessing outcomes.
- Collaborate with Regulatory Affairs to facilitate domestic and international regulatory submissions and approvals.
- Develop and uphold procedures and best practices to ensure compliance with applicable domestic and international cleaning, disinfection, and sterilization standards.
- Enhance cleaning, disinfection, and sterilization control processes, systems, and procedures.
- Assist in the creation of standardized reprocessing manuals for end-users, simplifying reprocessing complexities while ensuring adherence to AAMI and ISO standards for medical devices.
- Possess a comprehensive understanding of medical device industry standards and guidelines for reprocessing.
- Support field visits to central reprocessing customer sites and provide recommendations for optimizing reprocessing workflows.
- Engage in AAMI working groups to contribute to the development of new standards in this domain.
- Perform other duties as assigned.
To effectively fulfill the responsibilities of this position, candidates must 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 professional experience in the medical device industry, including at least 3 years in cleaning and sterilization validation.
- Experience with flexible endoscope cleaning, disinfection, and sterilization validation.
- Familiarity with US and international medical device cleaning, disinfection, and sterilization standards.
- Exceptional verbal and written communication skills, along with strong teamwork and interpersonal abilities.
- A self-starter mentality with the capacity to navigate a fast-paced environment.
- Ability to prioritize and manage multiple projects effectively.
- Hands-on experience and a proven track record of success in cross-functional team settings.
- Attention to detail coupled with the flexibility to support various projects.
- Proficiency in MS Office Suite, including statistical analysis tools.
- Willingness to travel to customer or laboratory sites (10%), including international travel.
Intuitive Surgical is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, prohibiting discrimination and harassment of any kind, regardless of 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 applicable laws.
