Engineer II, Manufacturing Engineering

QUASAR MEDICAL (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 90,000 - 120,000; Full time

Job summary

QUASAR MEDICAL (SINGAPORE) PTE. LTD. is seeking an experienced process engineer to manage new product introductions, process engineering, and sustaining activities in Singapore.

You will study product and manufacturing methods to develop and improve processes across Quasar Singapore, act as a senior team member, and mentor junior engineers. The role involves leading cross-functional teams, developing qualifications and validations, and ensuring GMP/ISO13485 compliance while driving cost and

Qualifications

• Bachelor in Engineering or similar technical field with 5–8 years’ experience in high-volume production.
• Medical Device Manufacturing experience preferred, especially catheter production techniques.
• Proficient in DOE and statistical techniques (SPC).
• Knowledgeable in defining process capabilities and control charting.
• Experience writing protocols for validations and qualifications including FMEA, IQ/OQ & TMV.

Responsibilities

• Evaluate and improve manufacturing processes through research, product design, and collaboration with vendors and operators.
• Design and develop processes for new products, changes, and enhancements, including tooling and fixtures.
• Troubleshoot processes, refine throughput, and design fixtures and assembly techniques.
• Improve efficiency by analyzing workflow, space, and equipment layout.
• Process qualifications and validations including equipment qualifications and material specifications.
• Lead process qualifications and validations, including equipment and material specifications.
• Ensure product and process quality through testing and establishing standards.
• Provide decision-making information by calculating costs and reviewing schedules.
• Prepare reports by analyzing and summarizing trends.
• Maintain equipment by coordinating maintenance and repairs.
• Ensure Health & Safety, including accident investigation and corrective action.

Skills

Interpersonal communication

DOE & SPC

Documentation & records

Change management

Self-motivation

Education

Bachelor in Engineering or related field

Tools

CAD software

Job description

Job Summary:

This role supports Singapore operations by managing new product introductions, process engineering, and sustaining engineering. Responsibilities include developing and improving manufacturing processes by studying product and manufacturing methods across all areas of Quasar Singapore

The candidate will cover duties and job assignment from product and/or process develop/ transfer/ improve manufacturing processes by evaluating/ assessing product drawings/prints and manufacturing methods in all areas of Quasar Singapore. Act as a senior team member, providing guidance and mentorship to junior engineers.

Essential Duties & Responsibilities:

Include the following. Other duties may be assigned.

• Evaluate and improve manufacturing processes through research, product design, and collaboration with vendors and operators.
• Design and develop processes for new products, changes, and enhancements, including tooling and fixtures.
• Troubleshoot processes, refine throughput, and design fixtures and assembly techniques.
• Improve efficiency by analyzing workflow, space, and equipment layout.
• Process qualifications and validations including equipment qualifications and material specifications.
• Lead process qualifications and validations, including equipment and material specifications.
• Ensure product and process quality through testing and establishing standards.
• Provide decision-making information by calculating costs and reviewing schedules.
• Prepare reports by analyzing and summarizing trends.
• Maintain equipment by coordinating maintenance and repairs.
• Ensure Health & Safety, including accidentinvestigation and corrective action.
• Investigate and evaluate new process technologies.
• Mentor and guide junior engineers by providing technical support, fostering professional development, and facilitating knowledge transfer.
• Lead cross-functional teams to drive continuous improvement initiatives and achieve operational goals.
• Develop and implement strategic plans for process improvements and new technology integration.
• Collaborate with senior management to align engineering activities with business objectives.
• Monitor industry trends and advancements to ensure the company remains competitive and innovative.
• Comply with EHS, ISO13485, GMP, FDA regulations, and GDP requirements.
• Any other project or duties as assigned.

Mentoring Process:

• Onboarding: Assist in the onboarding process of new engineers by providing comprehensive training on company processes, tools, and safety protocols.
• Regular Check-ins:Conduct regular one-on-one meetings to discuss progress, address challenges,and provide feedback.
• Skill Development:Identify skill gaps and provide opportunities for training and development,including workshops, courses, and hands-on projects.
• Knowledge Sharing:Facilitate knowledge transfer through documentation, presentations, andcollaborative projects.
• Performance Reviews:Participate in performance reviews, providing constructive feedback andsetting goals for professional growth.
• Support and Guidance:Offer continuous support and guidance, encouraging open communication and acollaborative work environment.

Key Performance Indicators(KPIs):

• Process Improvement: Number of successful process improvements implemented.
• Efficiency Gains: Percentage increase in production efficiency.
• Quality Metrics: Reduction in defect rates and improvement in product quality.
• Cost Savings: Amount of cost savings achieved through process optimizations.
• Project Timeliness: Percentage of projects completed on time.
• Compliance: Adherence to EHS, ISO13485, GMP, FDA regulations, and GDP requirements.
• Equipment Uptime: Percentage of equipment uptime and reduction in downtime.
• Health & Safety: Number of safety incidents and effectiveness of corrective actions.
• Innovation: Number of new technologies or processes evaluated and implemented.
• Team Development: Effectiveness in mentoring and developing junior engineers.
• Strategic Initiatives: Success in leading cross-functional teams and implementingstrategic plans.

Authority:

N/A

Education/Experienceand Qualifications:

• Bachelor in Engineering or similar technical field with 5 to 8 years’ experience in a high-volume production environment. Medical Device Manufacturing experience with knowledge of catheter production techniques is preferred
• Strong interpersonal skills with the ability to communicate effectively at all levels within thecompany.
• Proficient in DOE and statistical techniques (SPC)
• Knowledgeable in defining process capabilities and control charting.
• Strong and meticulous in documentation and record management. Ability to manage Engineering Change Order. Writing of protocols for validations and qualifications including FMEA, MVP, IQ/OQ & TMV protocol preparation.
• Proficiency with CAD software is required.
• Knowledge of GMPs, ISO 9001, ISO13485 and the Medical Device Directives
• Self-motivated and driver of change and innovation. Must be willing to work in a fast-pacedenvironment with minimum supervision.

Work Environment:

• While performing the duties of this Job, the employee is frequently exposed to moving mechanicalparts. The noise level in the work environment is usually moderate.
• Controlled Environment (Class 10K/100Kcleanroom) and office area.
• Occasional travel may be required.