Key Responsibilities
Lead Process Engineering team (Manufacturing Engineering and Equipment Engineering) in Penang, Malaysia enabling production and development of Instruments and Accessories for use in robotic procedures worldwide
Maintain and execute multi-year roadmap for capacity improvements including mid and high volume products. Responsibilities include product transfers, line duplications, factory automation, and efficiency improvements
Oversee the validation and qualification of manufacturing equipment and processes in compliance with medical device manufacturing standards (DQ/IQ/OQ/PQ/PPQ)
Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition, internal/external audits and Engineering Change Orders (ECO)
Hire, train, mentor and evaluate personnel to ensure efficient operation of process engineering functions. Build team culture aligned with Intuitive culture, motivate for higher performance, build local industry collaboration and develop team skills.
Define, measure, and maintain Key Process Indicators (KPIs) for critical performance metrics across plants utilizing data analytics tools and dashboards
Maintain close partnership with plant leadership in Production, Planning, Procurement, Master Scheduling, Supplier engineering, Industrial engineering and similar technical functions in support of operational excellence across Penang site.
Build strong trusted relationships with partners across the company, including manufacturing operations, quality, and engineering regional leaders.
Provide leadership for planning, staffing, budgeting, and project/program cost tracking
Travel to Intuitive plants globally (up to 50% Year 1, up to 20% future years)
Leadership Capabilities
Build, develop credibility and relationships at all levels of the organization to successfully drive functional, product and business objectives
Proven ability building strong teams and culture of continuous improvement through novel technological approaches and data driven engineering
Create an environment of high expectations and achievement. Challenge the organization and team to continuously improve and grow
Ownership of recruitment, retention and development of top talent. Provide coaching and mentoring to develop a leadership team and lead by example to model expectations of Intuitive’s values and behaviors.
Leverage Intuitive’s mission and goals and thoughtfully align local/functional objectives and goals to drive throughout the Process Engineering organization
Represents the organization in relations with its customers and business and non-business communities
Hands-on attitude, with a willingness to contribute at all levels
Key Position Requirements
Minimum BS degree in Engineering (Mechanical, Electrical / Electronics, Computer Science, Manufacturing , Biomedical or equivalent)
10+ years as an individual contributor or manager of technical personnel in a fast-paced environment.
3+ years leading large groups that include people managers preferred.
Hands on experience in leading validation and verification process within a regulated environment.
Strong analytic skills as proven by a track record for analyzing and fixing complex problems in products and processes.
Strong quantitative process development skills including (p)FMEA, tolerance analysis, DoE, SPC, GR&R, and Cpk.
Ability to communicate effectively and professionally across a range of technical disciplines with a broad slate of stakeholders, including management, peers, customers, and suppliers
Prior experience with the Design Control processes for medical devices and clinical application of surgical instruments and accessories is a plus
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred
Proficiency in Microsoft Office suite of productivity software.
High level of English speaking, reading, and writing (Bilingual).
Ability to travel to USA, Mexico, EU and Asia for Intuitive plants and supplier sites
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.
U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.
Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).
For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
