Senior / Manager, R&D Project Management

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

Reports to: Senior Director, R&D Project Management

Function: Research and Development

Role Overview

As a member of the Global R&D team, the R&D Project Senior / Manager (PM) leads projects in Class III Medical Device New Product Development (NPD), Quality Improvement, Molding Capacity Expansion and Geographic Expansion 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 medical device projects. The scope typically includes multiple projects involving intraocular lenses (IOLs) and/or inserters.
• 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.
• Involved in change control for manufacturing process and suppliers.
• Experience with successfully supporting global regulatory submissions and amendments.
• 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