Principal Engineer (Technical Lead)

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 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: Global R&D, Quality, and Manufacturing Teams

Reports to: Senior Director, R&D Project Management

Role Overview

The Principal Engineer will be solely responsible to manage a group of subject matter experts within a given project and be the right-hand support (technical lead) for the project manager to deliver on all technical matters in the project.

Duties and Responsibilities

Role Overview

The Principal Engineer (Technical Lead) will be solely responsible to manage a group of subject matter experts within a given project and be the right-hand support (technical lead) for the project manager to deliver on all technical matters in the project.

Duties and Responsibilities

• Coordinate and lead a team of subject matter experts) e.g. Optics, Mechanical, Process, Materials, Plastics, Molding, Biocom) ensuring alignment of technical deliverables with project timelines.
• Serve as the technical representative on the project core team, working directly with the project manager and being responsible and accountable for the delivery of all technical aspects of a project by the technical sub team
• Be able to understand all aspects of technology without being an SME in order to ensure all SMEs deliver to the quality and timeline of a given project.
• Be knowledgeable of all design control procedures for medical device design, developement, verification and validation.
• Lead risk assessment activities, and be a strong partner with QA and Mfg Ops.
• Be the lead on projects to discuss and address any technical issues
• Be the technical lead for projects through launch and post-launch.
• Develop and follow standardized technical documentation.
• Be responsible for high quality technical documentation for regulatory submissions across the globe.

Requirements

Experience

• 5-10 year of experience with design & development of Class IIb or Class III medical devices, including demonstrated experience leading multi-disciplinary technical teams
• At least 2 years of experience coordinating and delivering complex techincal projects in a medical device environment
• Proven work experience as a senior level process engineer in the medical device industry
• Thorough knowledge of medical device development, including design control and risk management processes
• Working knowledge of plastics and molding
• Experience working with SolidWorks and/or CAD preferred

Skills/Accreditations

• Excellent communication skills
• Strong skills in statistics and data-driven decision making
• Demonstrated ability to build and maintain effective relationships across functions, influence stakeholders, and drive technical consensus

Academic Qualifications

• A minimum Bachelor’s degree in Mechanical strongly preferred, but Biomedical or Chemical Engineering acceptable.
• Master’s degree in the above fields strongly preferred.

Travel requirements

• International travel up to 20%