Sr. Manager, Process Engineering

Intuitive; Penang; On-site; MYR 420,000 - 640,000; Full time

Job summary

Intuitive's Penang, Malaysia plant seeks a Sr. Manager to define and execute the strategic vision for Process Engineering. You will lead the instruments and accessories manufacturing, drive continuous improvement, and oversee validation and qualification of processes and equipment.

You will build and mentor a high-performing team, manage KPIs, and collaborate with production, planning, procurement, and supplier functions to achieve manufacturing excellence. International travel is expected.

Qualifications

• Lead Process Engineering team in Penang for instruments and accessories worldwide.
• Manage multi-year capacity roadmap including product transfers, line duplications, and automation.
• Oversee validation and qualification of equipment and processes per medical device standards.
• Hire, train, mentor, and evaluate personnel; cultivate high-performance culture.
• Define and monitor KPIs for performance across plants using data analytics.
• Collaborate with plant leadership across production, planning, procurement, scheduling, and suppliers.
• Travel to Intuitive plants globally as needed (up to 50% Year 1).

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 multi-year capacity roadmap including product transfers, line duplications, factory automation, and efficiency improvements
• Oversee validation and qualification of manufacturing equipment and processes in compliance with medical device standards (DQ/IQ/OQ/PQ/PPQ)
• Maintain compliance with medical device quality system including CAPA, material disposition, audits and ECOs
• Hire, train, mentor and evaluate personnel to ensure efficient operation of process engineering functions.
• Define, measure, and maintain KPIs for critical performance metrics across plants using data analytics tools and dashboards
• Travel to Intuitive plants globally (up to 50% Year 1, up to 20% future years)

Skills

Process Engineering

Manufacturing Engineering

Leadership

Project Management

Validation & Qualification

Data Analytics

Medical Devices

Education

BS degree in Engineering

Job description

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.

Job Description

What We Are Looking For

Sr. Manager, Process Engineering

within the Multiport Process Engineering team located in our Penang, Malaysia plant. This is an exciting leadership opportunity to define and implement Intuitive’s strategic vision for our Penang Malaysia factory. This technical leadership role in Process Engineering for Instruments and Accessories will lead activities from initial site bring up, product transfer, qualifications and long term manufacturing activities at the plant. Sustaining responsibilities include continuously improving manufacturing processes, equipment, and testing to ensure improved product quality, reliability, manufacturability, efficiency, capacity and costs. This technical leader will define and execute the strategic plan for engineering and drive timely and high-quality execution of projects through management and mentoring of direct reports as well as the utilization of personal expertise.

Qualifications

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

Additional Information

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