Senior Manufacturing Engineer

Insulet Corporation; Malaysia; On-site; MYR 80,000 - 100,000; Full time

Job summary

A leading medical device company in Malaysia is looking for a Senior Manufacturing Engineer to drive product and process improvements while managing equipment validation. The ideal candidate has over 6 years of experience in a manufacturing environment related to medical devices and is proficient in data analysis and lean manufacturing concepts. This full-time position offers opportunities for professional development and international travel.

Qualifications

• 6+ years of experience in a manufacturing environment, preferably in medical device.
• Proficient in data analysis and proficiency in Six Sigma/Lean concepts.

Responsibilities

• Drive product and process improvements in support of operations.
• Support equipment validation and continuous improvement activities.
• Monitor KPIs related to project budget, timing, and efficiency.

Skills

Proficient in all Microsoft Office tools

Excellent Microsoft Excel and Data Analysis Skills

Working knowledge of Minitab and/or JMP statistical analysis software

Working Knowledge of Solidworks and print reading

Proficient in Six Sigma/Lean manufacturing concepts

Comfortable troubleshooting mechanical equipment

Basic knowledge of common challenges with assembly

Strong command of structured problem-solving tools

Strong project management skills

Education

BS. in Mechanical/Industrial/Electrical Engineering with 6+ years of medical device experience

Job description

Senior Manufacturing Engineer page is loaded

Senior Manufacturing Engineer

Apply locations MY - Malaysia (Office) MY - Malaysia time type Full time posted on Posted Yesterday job requisition id REQ-2025-11987

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

Position Overview:

The candidate will work both on the addition of new manufacturing lines and equipment, as well as continuous improvement efforts for existing manufacturing processes/equipment.

The candidate will build and apply knowledge of Omnipod product function and manufacturing assembly processes to coordinate with equipment suppliers, CM counterparts, and various teams within Insulet to ensure the successful validation and performance of new and existing manufacturing equipment and processes.

The candidate will be responsible for KPIs for project budget and timing, as well as machine up-time, process yield and efficiency once equipment is in production.

As part of providing support to the Global Manufacturing Engineering Group, the candidate will also carry out root cause investigations using structured problem-solving tools and will author and review quality system documentation such as validations, work instructions, SOPs, non-conforming material investigations, and tool files.

Responsibilities:

• Drive product and process improvements in support of Insulet's Operations (3) main objectives;
• Best Quality
• Highest Efficiency
• Lowest cost

• Project deliverables for installation of new manufacturing equipment and manufacturing equipment upgrades
• Support equipment validation and continuous improvement activities at Insulet manufacturing facilities
• Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing, and support.
• Monitor and report on yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above target
• Develop and drive Continuous improvement efforts.
• Generate validation/qualification (IQ, OQ, TMV, CSV, PQ) protocols, coordinate the execution of the validation/qualification protocols and write validation/qualification final reports
• Possesses strong mechanical analysis skills
• Analyze a product using mechanical engineering methods such as FBD analysis and fundamental physics.
• Use standardized root cause investigation templates and problem-solving tools to carry out non-conforming material investigations
• Implement corrective and preventive actions
• Support new product introduction initiatives
• Travel to key suppliers to help them carry out critical investigations or improvement projects
• Carry out duties in a quality system environment
• At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device manufacturing.
• Author and implement Engineering Change Orders
• Up to 5% travel required, ability to travel internationally
• Performs other duties as required

Skills/Competencies:

• Proficient in all Microsoft Office tools
• Excellent Microsoft Excel and Data Analysis Skills
• Working knowledge of Minitab and/or JMP statistical analysis software
• Working Knowledge of Solidworks and print reading
• Proficient in Six Sigma/Lean manufacturing concepts
• Comfortable troubleshooting mechanical equipment both Semi and fully automated
• Basic knowledge of common challenges with assembly of molded components, stamped metal, and springs
• Strong command of structured problem-solving tools
• Strong project management skills

Behavioral Competencies:

• Decision Making – has a systematic and methodical approach to making decisions, seeks out and explores relevant information, thinks creatively beyond the immediate problem, assimilates facts quickly, challenges assumptions, and considers business implications of potential solutions.
• Communication Skills – Conveys information effectively, actively listens, resolves conflict constructively.
• Work Organization – Takes a structured, economical approach to resources including time, people, money, and equipment.
• Problem Solving – Uses a systematic, methodical approach to gather facts, define problems, generate and implement solutions.
• Initiative – Makes decisions and takes actions appropriately. Willing to take risks as circumstances require.
• Planning Skills – Sets goals and priorities, thinks ahead, identifies activities and resources needed to achieve goals.
• Perseverance – Achieves objectives by overcoming difficulties through tenacity and resilience.

Education and Experience:

• BS. in Mechanical/Industrial/Electrical Engineering preferably in 6+ years of medical device experience (manufacturing environment)

About Insulet

Insulet Corporation is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Insulet employees are all focused on the same goal — to make a difference. Our relentless passion is to simplify life for people with diabetes. We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance. We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there. We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers. Our innovation spirit and customer-centric focus position us as global pioneers — leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.