Molding Engineer

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.

HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.

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 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 themselves and are impact-focused,
- Consider the needs, challenges, and objectives of every person with whom they interact, and
- Exhibit positive reinforcement to help others succeed.

**About the role**

**Works closely with and have impact on**:Manufacturing Engineering, Supplier Quality

**Reports to**:Senior Molding Engineering Manager

**Function**:Global Research & Development

**Work Location/Site**: Singapore / Global Headquarters

**Role Overview**

This position is responsible for the plastic injection tooling and molding project management of new product developments, transferred projects, capacity expansion, as well as continuous improvement for production tooling.

**Duties and Responsibilities**
- Plan and manage molding engineering budget
- Support all molding engineering related projects
- Lead projects related to quality, yield, process efficiency, and capacity improvement
- Lead end-of-life issues pertaining to product materials and components
- Lead qualifications of 2nd source of materials or equipment for business continuity

In New Product Development Support,
- To be accountable as project leader for tooling development from prototype until mass production stage. Tasks are included but not limited to below aspects:

- Manage the tooling project to ensure project timeline, capital investment and tooling performance target are consistently met
- Review and provide valuable input to Design For Manufacturing (DFM) documents from mold maker, and to assist R&D product designers to optimize product design from tooling scalability and best molding production cost perspective
- Analyze and understand product design, generate mold specification and acceptance criteria, conduct mold design review
- Oversee mold, equipment, process testing and debugging, conduct testing result review and drive mold performance improvement
- Document and transfer tooling knowledge from 1 cav prototype to multi cav mass production tooling
- Molding supplier factory molding validation IQ/OQ/PQ review
- Collaborate with in-house manufacturing and quality team to qualify new tooling. The tooling are for injector parts, IOL optical PP mold, and process aids for material production
- Compile tooling and molding related documentation in accordance to the regulatory requirements, and maintain the quality of molded components
- Initiate the Change Control submission and review, conduct Risk Assessment, draft and get Validation Plan, Validation Protocol/Report reviewed and approved based on the project master plan

In Sustaining Engineering
- Monitor and evaluate production tooling performance at vendor sites and lead the project to develop new tooling for capacity expansion and replacement/renewal
- Trouble shoot IOL and injector defects potentially related with injection molding production which occurs in the vendor’s manufacturing site (Japan, Singapore, Malaysia, etc.), drive solutions with data analysis and fact-based approach
- Be involved in sourcing of alternative vendor of plastic tooling and molding production for long term business sustainability

**Requirements**:
**Experience**
- At least 3 years of technical experience in medical device/pharmaceutical industry
- Understand IQ/OQ/PQ validation requirement in accordance with IS013485 standard
- Able to write, review and coach validation protocol and report
- Track record of successful tooling and molding project management, tool makers and molding suppliers handling experience in the region
- At least 3 years of hands on experience in tool