Job Description
Primary Function of Position
Senior Mechanical Engineer for Equipment shall design, duplicate, construct pioneering manufacturing equipment used to produce minimally invasive medical devices. This manufacturing equipment will range in complexity from custom manual fixtures to automated electromechanical systems, integrating functions such as electronic sensing, motion control, and machine vision. This position will play a critical role in developing cutting edge manufacturing capabilities to enable the future of minimally invasive surgery.
The ideal candidate will have experience duplicating, transferring, maintaining and improving custom automated equipment from global Intuitive sites to Penang, Malaysia plant. This individual shall have demonstrated proficiency in mechanical design and the integration of electromechanical components and robotics and will thrive working independently on complex projects. This individual will be capable of successfully leading teams in design and validation, while mentoring other engineers. As a senior engineer, this individual will identify projects, build teams, improve sustaining production lines and take ownership to deliver results.
Key Responsibilities
Lead equipment 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 duplication, transfer, set up, PMC, validation and qualification of manufacturing equipment (DQ/IQ/OQ/PQ).
Provide day to day line support to manufacturing lines in Penang, Malaysia for all Equipment Engineering related activities.
Quality Notifications: Review, provide technical support, address root cause and disposition discrepant 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. Conceive, design, document, procure and build manufacturing equipment deemed proprietary to Intuitive Surgical to help plant achieve goals
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 engineering documentation, including Work instructions (MPI's, Periodic Maintenance & Calibration, Acceptance criteria, etc.), Operating procedures (SOP's, DOP's, etc.), Qualification Protocols, Qualification reports.
Specify requirements for manufacturing equipment which may be designed and fabricated by third parties and jointly develop custom tooling.
Perform engineering studies to characterize equipment process windows.
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 experience developing, transferring and qualifying equipment used in Mid/high volume complex mechanism manufacturing in a fast-paced environment.
High level of English speaking, reading, and writing (Bilingual).
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 is a plus
Familiarity with Robot programming (Fanuc, Denso) C/C++, and Python is a plus
Strong technical analytical skills including motion control algorithms is a plus
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
candidate’s qualifications, consistent with applicable law.
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.
