Sr. Manufacturing Engineer

Intuitive; Penang; On-site; MYR 150,000 - 190,000; Full time

Job summary

Intuitive Surgical in Penang is seeking a Senior Manufacturing Engineer to lead transfers of Instruments & Accessories to the local site and to deliver improvements in reliability, cost, manufacturability, and serviceability. You will mentor engineers and work across mechanical, electrical, and software disciplines.

You will oversee equipment validation, contribute to DFA/DFM, and ensure documentation quality while driving continuous improvement and meeting medical device standards.

Qualifications

• BS in Engineering or equivalent; MS preferred.
• Experience leading validation and verification in regulated environments.
• Strong analytical and problem-solving capabilities.

Responsibilities

• Lead transfers of Instruments & Accessories production lines to Penang.
• Oversee equipment validation and qualification (DQ/IQ/OQ/PQ/PPQ).
• Provide day-to-day line support and drive continuous improvement.
• Develop DFA/DFM input to standardize products and processes.
• Create and revise manufacturing/engineering documents (SOPs, work instructions).
• Support supplier quality issues and implement corrective actions.
• Define KPIs and monitor performance across plants.

Skills

Analytical thinking

Cross-functional collaboration

Problem solving

Communication skills

Education

Bachelor's degree in Engineering

MS in Engineering preferred

Tools

Microsoft Office

Solid modeling

Validation tools

Job description

• Ways of Working: Onsite - This job is fully onsite.


• Employee Type: Employee


• Global Job Level (HCM): Professional 4 (11)

Company Description

Advancing minimally invasive care — it’s the passion that drives us at Intuitive. As the industry pioneer, we pair ingenuity with intelligent technology to make a difference in the world. For more than 30 years, we have developed new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

At Intuitive, we are doing work that matters — our outstanding team has dedicated their life’s work to expanding the potential of physicians, so their patients get back to what matters most. As we move into new areas and explore new technologies, we believe there is still tremendous opportunity to do great work in support of our mission.

As pioneers, we’re not afraid to challenge the status quo and attempt what others view as impossible. We actively invest in our people to support their growth and contribution. Among our team, mutual respect, inclusive practices and diversity of thought are a must — we believe a great idea can come from anywhere.

Join a passionate team who is committed to making a difference for our customers, surgeons and their patients around the world. Together, let’s advance the world of minimally invasive care.

Job Description

Primary Function of Position:

Sr. Manufacturing Engineer is responsible for transfers and supporting production released assembly lines for instruments & accessories. Plan and deliver improvements in reliability, cost, manufacturability, and serviceability. Lead a team of Engineers as well as cross-functional teams, providing support in product/process documentation and criteria; as well as in mechanical, mechatronics, electrical and electronics disciplines. Contribute with his/her technical skills in the areas of manufacturing, problem solving and training. Lead and schedule production line transfers of new products from global Intuitive plants.

Lead a team of Engineers as well as cross-functional teams, providing support in product/process documentation and criteria; as well as in mechanical, mechatronics, electrical and electronics disciplines.

Contribute with his/her technical skills in the areas of manufacturing, problem solving and training.

Lead and schedule production line transfers of new products from global Intuitive plants.

Key Responsibilities

• Lead manufacturing engineering activities to transfer Instruments & Accessories production lines from global plants to Penang, Malaysia site. Transfer activities shall include duplication of equipment, training on manufacturing processes, business processes and qualifications with medical device manufacturing standards.


• Oversee the validation and qualification of manufacturing equipment and processes (DQ/IQ/OQ/PQ/PPQ).


• Provide day to day line support to manufacturing lines in Penang, Malaysia for all Engineering related activities.


• Quality Notifications: Review, provide technical support, address root cause and disposition discrepant material or products or equipment and implement corrective actions to prevent recurrence.


• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.


• Provide Design Engineering input for Design for Assembly / Manufacturability (DFA/ DFM) to ensure standardization across various products and processes.


• Creation, revision and/or approval of manufacturing and engineering documentation, including: Work instructions (MPI's, Acceptance criteria, etc.) Operating procedures (SOP's, DOP's, etc.), Qualification Protocols, Qualification reports.


• Help resolve supplier quality issues involved in assembly lines or products transfers into our facilities, including planning, validation/verification and final implementation.


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


• Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition, internal/external audits and Engineering Change Orders (ECO).


• 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.


• Travel to Intuitive plants globally (up to 50% Year 1, up to 20% future years)

Qualifications

Key Position Requirements

• Minimum BS degree in Engineering (Mechanical, Electrical / Electronics, Computer Science, Manufacturing , Biomedical or equivalent), MS in Engineering preferred.


• 8+ years mechanical or manufacturing engineering experience with Mid/high volume complex mechanism manufacturing in a fast-paced environment.


• 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, Failure Analysis 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


• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment preferred


• Proficiency in Microsoft Office suite of productivity software.


• Prior experience in Solid modeling, prototyping and implementing changes is a plus


• 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 employeeswho 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’sstart 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
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.

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