Senior Manufacturing Engineer

Insulet; Gelang Patah; On-site; MYR 80,000 - 120,000; Full time

Job summary

A medical device company based in Gelang Patah, Malaysia, is seeking a Manufacturing Engineer with at least 6 years of experience in a medical device environment. You will be responsible for improving manufacturing processes, validating new equipment, and managing project deliverables. Strong proficiency in Microsoft Office and problem-solving skills are required. The role includes some international travel and adherence to cGMP and FDA guidelines.

Qualifications

• 6+ years in medical device manufacturing environment.
• Strong command of structured problem-solving tools.
• Experience in continuous improvement efforts.

Responsibilities

• Drive product and process improvements for Insulet's Operations.
• Support equipment validation and project deliverables.
• Analyze products using mechanical engineering methods.

Skills

Microsoft Office proficiency

Excel and data analysis skills

Minitab or JMP knowledge

Solidworks knowledge

Six Sigma/Lean concepts

Mechanical equipment troubleshooting

Problem-solving tools

Project management skills

Education

BS in Mechanical/Industrial/Electrical Engineering

Job description

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)