Senior Manufacturing Equipment Engineer

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

Job summary

A leading medical device manufacturer is seeking an experienced engineer to enhance manufacturing lines and processes. This role requires a BS in Engineering and 6+ years in medical manufacturing. You will coordinate with suppliers, support equipment validation, and drive continuous improvements. Strong mechanical analysis and problem-solving skills are essential for success, along with proficiency in relevant tools. Up to 5% travel is required, including potential international trips.

Qualifications

• 6+ years of experience in a medical device manufacturing environment.
• Proficient in Six Sigma/Lean manufacturing concepts.
• Comfortable troubleshooting mechanical equipment.

Responsibilities

• Drive product and process improvements.
• Support equipment validation and continuous improvement activities.
• Monitor and report on yield and equipment up-time.

Skills

Mechanical analysis skills

Data Analysis Skills

Problem Solving

Communication Skills

Project Management

Education

BS in Mechanical/Industrial/Electrical Engineering

Tools

Microsoft Office

Minitab

JMP

Solidworks

Job description

Department: Global Manufacturing Engineering

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

Education & Experience

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

Preferred Skills and 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
• 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.