Senior Engineer, Technology Transfer

HOYA MEDICAL SINGAPORE PTE. LTD.; Pasir Panjang; On-site; MYR 80,000 - 110,000; Full time

Job summary

A leading medical technology company in Malaysia is seeking a Process Validation Engineer to establish and validate mass production processes for new and improved products. The ideal candidate will have 3-6 years of experience in the medical device industry and strong skills in process validation, quality engineering, and risk management. This role involves close collaboration with R&D and manufacturing teams and contributes to ensuring compliance with medical device regulations.

Qualifications

• 3 – 6 years of industrial experience in a regulated medical device or life science environment.
• At least 3 years of production experience in manufacturing, process improvement or process development.
• Good understanding of global medical device regulations and standards (e.g. GMP, ISO 13485, FDA, EU MDR).

Responsibilities

• Provide input to new process design based on manufacturability.
• Plan, establish and execute feasibility studies and process validation.
• Drive design transfer activities for smooth handover from R&D to manufacturing.

Skills

Process validation

Quality engineering

Risk management

Documentation skills

Verbal communication

Education

Bachelor's or Master's degree in science and engineering

Job description

HSO way of working

In fulfilling our roles, we are

• Accountable for our own capabilities and development.
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who

• See beyond self and are impact focused.
• Consider the needs, challenges, and objectives of every person they interact with
• Exhibit positive reinforcement to help others succeed.

Job Description

About the role

Works closely with and have impact on: R&D, Operation, QA, SCM

Reports to: Senior Manager of Technology Transfer

Function: Global R&D, Material and Process Engineering

Role Overview

This role is responsible for establishing and validating mass production process of new products and improved products, involving IQ, OQ and PQ, with approved development specifications. Lead and ensure successful design transfer to Manufacturing Engineering/ Production, while keeping the approved project timeline.

Duties and Responsibilities

Perform the following tasks in assigned projects

• Provide input to new process design based on manufacturability
• Plan, establish and execute feasibility studies and process validation for new products with approved development specifications to meet approved pipeline
• Drive design transfer activities, ensuring smooth handover from R&D to manufacturing and maintaining design intent in production
• Lead process validation activities in IQOQ, and support PQ
• Provide training to Manufacturing and/ or Production
• Conduct risk assessments
• Other duties as assigned by the unit manager. This might include assignments working closely with other units and support of potential product development activities.

Requirements

Experience

• 3 – 6 years of industrial experience in a regulated medical device or life science environment
• At least 3 years of production experience in manufacturing, process improvement or process development
• Cross-functional working experience is a plus

Skills/Accreditations

• Good understanding of process validation, quality engineering and risk management
• Familiarity with global medical device regulations and standards (e.g. GMP, ISO 13485, FDA, EU MDR, PMDA) is desired
• Statistical skill is desired
• Good documentation and report writing skills
• Good verbal and written communication skills

Academic Qualifications

• Bachelor's or Master's degree in science and engineering or related fields.

Travel requirements

• 10 to 30%

By submitting your application, you consent to HOYA Group collecting, disclosing, and retaining your personal data for employment assessment and verification purposes.

If you are shortlisted, we will contact you within three weeks of your application. Thank you for your application and understanding.