Manufacturing Engineering (ME) Manager

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: Senior Director ME, Hoya Medical (Suzhou) Co. Ltd. (HMSZ)

Role Overview

In the first phase of the establishment of China Manufacturing, the incumbent will plan and lead production equipment installation, prepare all materials required for validation activities as planned (Protocol, report and execution, including IT system readiness).

In the second phase, he/she will ensure commercial manufacturing occurs as per plan to achieve quality, COGS, and yield improvement. This will require excellent cross function collaboration with QA, RA, IT, and finance.

Duties and Responsibilities

- Manage product transfers from Thailand

- Support new process implementation

- Assist with the training of new employees

- Budget for the new processes

- Assign ME team members to tasks based on expertise

- Achieve yield improvement

- Achieve product cost (COGS) objectives and efficiency

- Sustain manufacturing

- Skills and competency development

- Manage ME budget (CAPEX, OPEX, Headcount)

- Work closely with QA to ensure quality standards compliance and qualification

Requirements

Experience

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

Skills/Accreditations 

- Leadership qualities

- Able to communicate effectively in English and Mandarin.

- Ability to communicate in Japanese is a plus

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

- Ability 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 

- 10-20% of time to Japan, Singapore, and/or Thailand