Senior Engineer / Engineer (Manufacturing Engineering)

About HOYA Surgical Optics (HSO)

HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.

At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.

HSO Way of Working

In fulfilling our roles, we are

• Accountable for own capabilities and development.
• Focused on delivering results with 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: Production, RA, QA, 

Reports to: Manager of ME Department, Hoya Medical (Suzhou) Co. Ltd. (HMSZ)

Role Overview

This role plan and execute production ME projects to support factory validation after construction. This will require equipment and process validations, including sterilization validation. After factory and product approval for manufacturing, the focus will will be to improve quality, yield, and capacity enhancement. lastly, the incumbent will support business needs by assisting in new product transfers to production, develop good relationships and communications with critical equipment and material vendors in China, Japan, Thailand, and Singapore.

Duties and Responsibilities

- Plan and execute projects related to quality, yield, process efficiency and capacity improvement related to Intraocular Lens (IOL) manufacturing.

- Take on Lead for operation in new product or process development and transfer activities

- Assume trainer role for ISO related testing

- Execute IQ/OQ/PQ for new equipment

- Design new equipment or jigs and fixtures to improve process efficiency and sustainability

- Manage end-of-life issues for products, materials, and components

- Support projects through regular communication with vendors

- Train and mentor engineers and assistant engineers in ME

Requirements

Experience

• At least 5 years of working experience in the Class III Medical Device Industry

Skills/Accreditations 

- Experience in Machining - Lens Machining, inspection, and packaging

- Effective communication in English and Mandarin is essential.

- Japanese is a plus.

- Basic project management skills to lead/participate in cross functional group activities (Mainly R&D, ME, Production, and Supply Chain) for new products and process installation

- able to plan, write and execute as per feasibility plans and validation protocols and reports.

Academic Qualifications 

• Degree in Engineering, or relevant qualifications with relevant working experience, preferably in the medical device industry

Travel requirements 

- 10-15% of time to Japan, Singapore, and/or Thailand