Onsite Senior Process Engineering Leader — Medical Devices

Intuitive; Penang; On-site; MYR 300,000 - 540,000; Full time

Job summary

Intuitive in Penang, Malaysia seeks a Sr. Manager, Process Engineering to define and implement strategic plans for the Penang factory.

You will lead a team across Manufacturing and Equipment Engineering, driving capacity, transfers, and line automation to support robotic instruments worldwide. You will oversee validation, quality systems, and cost control while mentoring a team and collaborating with production, planning, and supplier engineering.

Qualifications

• Minimum BS degree in Engineering.
• 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

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).
• 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.
• Define, measure, and maintain KPIs for critical performance metrics across plants utilizing data analytics tools and dashboards.

Skills

Leadership

Data analytics

Process engineering

Validation & verification

Communication

Strategic planning

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Microsoft Office

Job description

Intuitive in Penang, Malaysia seeks a Sr. Manager, Process Engineering to define and implement strategic plans for the Penang factory.

You will lead a team across Manufacturing and Equipment Engineering, driving capacity, transfers, and line automation to support robotic instruments worldwide. You will oversee validation, quality systems, and cost control while mentoring a team and collaborating with production, planning, and supplier engineering.