Technical Program Manager, Product Development
Overview:
In this role you will lead cross-functional NPD programs for the Light Adjustable Lens (LAL) and accessories from concept to launch. You'll connect R&D, manufacturing, supply chain, quality, clinical, regulatory, and commercial teams to deliver integrated plans, rigorous studies, and compliant documentation. You'll elevate program practices, drive timely delivery, and accelerate time-to-market in a fast-paced, innovative environment. This position offers meaningful impact on patient outcomes and the company's mission to optimize cataract surgery results.
Responsibilities:
- Lead cross-functional NPD and change control programs from concept through commercial launch
- Define integrated NPD program plans with scope, milestones, deliverables, risks and dependencies
- Lead cross-functional program meetings and ensure decisions and ownership are documented and followed upTranslate user needs and performance targets into structured roadmaps and plans
- Create and finalize design history file documentation including risk management, development requirements, and study reports
- Plan and lead feasibility, characterization, verification, and validation studies and associated activities
- Collaborate with Regulatory and Quality to align activities with quality systems and submission strategies
- Coordinate with Manufacturing Operations and Global Supply Chain for manufacturing transfer and ramp-upProvide clear status updates and dashboards; adjust plans based on new information
- Improve program governance, controls, and tailormade processes for scalable execution
- Ensure smooth handoff from development to manufacturing transfer and production ramp-upFoster proactive cross-functional communication and collaboration across all functions
Key requirements:
- Strong understanding of regulated medical device product development (requirements definition, feasibility, verification, validation, manufacturing transfer, post-market change control)
- Knowledge of design controls, quality systems, and risk management (21 CFR 820, ISO 13485, ISO 14971)
- Excellent analytical and systems thinking for interpreting data and identifying trends
- Ability to balance program leadership with hands-on technical contribution
- Excellent written and oral communication tailored to diverse audiences
- Proven track record coordinating complex, cross-functional programs to on-time delivery
- Experience with project tools (Smartsheet, MS Project) and data systems (Power BI, electronic quality management system)
- Experience with external partners (consultants, test labs, suppliers)
- Self-motivated, proactive, and able to work with minimal supervision
- Bachelor's degree in Chemical Engineering (or closely related) + 6+ years in medical device development; 3+ years leading cross-functional teams
- Experience with GMP/GDP/GLP a plusstrong communicationcross-functional collaborationproactive problem-solving
- SmartsheetMS Project
- Power BI