Sr./ R&D Project 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.

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: R&D, Quality, Operations, Regulatory Affairs, Clinical Affairs, Supply Chain, Marketing

Reports to: Senior Director, Project Management

Function: Research and Development

Work Location/Site: Singapore/Global Headquarters

Role Overview

As a member of the Global R&D team, the R&D Project Manager (PM) leads projects in New Product Development (NPD), Quality Improvement, Global Expansion, and Maintenance of Business to drive business growth and continuous improvement in manufacturing. The R&D PM leads diverse cross-functional project teams and employs sound project management methods.

Duties and Responsibilities

• Provide project management leadership to R&D-led projects. The scope typically includes multiple projects.
• Lead core teams of cross-functional members, demonstrate passion for Science and Engineering.
• Foster collaboration with various functions such as Operations, Supply Chain, QA, RA, Clinical and Marketing.
• Gather requirements and develop comprehensive project management plans to meet requirements.
• Delegate project workstreams and tasks effectively and hold project teams to accountability.
• Monitor and control projects, deliver milestones on time, within scope and within budget.
• Report progress and variance to plan with transparency to management and governance as required.
• Continuously drive identification of risks and mitigations in the project workstreams.
• Communicate project progress, risks, issues, and project needs on a regular basis.
• Use common methods to define problems, identify gaps in performance, and design solutions.
• Keep abreast of best practices in project management and encourage wider adoption.

Requirements

Experience

• At least 5 years industrial experience in project management in medical devices marketed under ISO 13485. Class III or Class IIb implantable medical devices preferred.
• Proven experience taking accountability for projects with successful goal achievement history including under Design Control. Experience leading or participating in Agile/Hybrid project teams preferred.
• Experience in Six Sigma methodologies, e.g. Lean or DFSS.
• Demonstrated experience engaging with senior management.
• Experience with successfully supporting global regulatory submissions and amendments.
• Involved in change control for manufacturing process and suppliers. Experience as a change agent is a plus.
• Proven experience working with contracted vendors and labs is a plus.

Skills/Accreditations

• Ability to think critically and innovatively combine willingness to challenge status quo.
• Although not necessarily a subject matter expert, know enough of each function to ask right questions, knows risks and keep deliverables on track.
• Skilled in Project Management software.
• Excellent standard of work delivery and technical documentation skills, incorporating Good Documentation Practices.
• Excellent communication and presentation skills, both verbal and written.
• Ability to engage, negotiate, and influence senior managers and stakeholders across discipline, function, and geographical boundaries.
• Detail-oriented and ability to make decisions based on facts.
• Self-starter with excellent organizational skills.
• Self-awareness and good work ethics.

Academic Qualifications

• Bachelor’s degree in science or engineering or a relevant field.
• Project Management certification (e.g., PMP) and Six Sigma certification preferred

Travel requirements

• Up to 20%, typically within Asia, but may need to travel to Europe or the USA