What are the responsibilities and job description for the Sr. Cleanroom Engineer position at Intuitive?
Company Description
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:
The cleanroom engineer is the ISI subject matter expert for Controlled Environment Room (CER) regulatory standards and compliance, operational procedures, and industry best practices. Manage and continuously improve CER operating procedures and controls and drive implementation across the organization.
Roles & Responsibilities:
- Specify and participate in new CER designs, startup, and validations
- Develop CER specifications and operating procedures as needed for new product, process, or regulatory requirements.
- Review, manage, and approve changes or modifications to CERs, new processes, equipment, and materials.
- Develop, promote, and implement CER operations training programs and initiatives
- Train, coach, and advise colleagues and new hires as needed for problem solving, risk management, and CER best practices
- Specify, review, and approve consumable operating and cleaning supplies
- Challenge, continuously improve, and document CER cleaning methods, frequency, and efficacy
- Document requirements and assist in evaluating new CER service suppliers for capability, infrastructure, and compliance. Ensure CER service suppliers are trained to relevant ISI procedures
- Drive consistent practices across all sites, domestic and international
- Drive, manage and review environmental and product nonconformance issues
- Subject matter expert for cleanroom operations during quality and regulatory audits, such as FDA, MDSAP, and other governments and agencies
Qualifications
Skills, Experience, Education, & Training:
- Minimum 10 years of relevant experience in a medical device or pharmaceutical company
- Minimum Bachelor’s degree or higher in Engineering, Microbiology, Quality, or similar
- Demonstrated understanding of medical device QMS and regulatory requirements, including but not limited to FDA CFR 21 820, ISO13485, ISO14644, ISO14698, IEST RPs.
- Demonstrated understanding of engineering change controls, process verification and validation, and production and process controls in a medical device Controlled Environmental Room
- Experience with developing and maintaining Standard Operating Procedures and Work Instructions
- Experience with the startup and validation of new facilities
- Participation in internal /external quality and regulatory compliance audits
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 Employment 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.
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.
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 salary ranges are listed.
