Job Type
Full-time
Description
OVERVIEW:The Technical Program Manager, New Product Development (TPM, NPD) will serve as a cross-functional program owner for the next generation of RxSight's Light Adjustable Lens (LAL) and its accessories, leading critical NPD programs from early concept and feasibility through development, verification and validation, regulatory approval, manufacturing transfer, and commercial launch. This role combines structured program leadership, systems thinking, and hands-on technical contribution: the TPM will define and own integrated NPD program plans, drive high-quality technical studies and design control documentation, and continuously elevate NPD program management practices and outcomes across a dynamic NPD ecosystem.
The TPM will develop sufficient working knowledge of key product attributes, risks, and processes to connect specialist input, orchestrate and complete integrated plans, manage interdependencies, and drive strategic programs that enhance product performance, quality, and manufacturability, and accelerate time-to-market. The TPM will partner closely with R&D, Manufacturing Operations, Global Supply Chain, Commercial, Quality, Clinical, and Regulatory teams, championing cross-functional collaboration and synergy. The TPM will act as a central hub for strong team communication, and serve as a trusted leader who organizes complex work, motivates and empowers the entire cross-functional team, ensures clear ownership and follow-through, and maintains the momentum and focus of a fast-paced, innovative NPD program.
Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES:Own and Orchestrate NPD Programs- Lead cross-functional NPD and change control programs for the RxSight Light Adjustable Lens (LAL) and accessories from early concept and feasibility through development, verification and validation, regulatory approval, manufacturing transfer, and commercial launch.
- Define and own integrated NPD program plans, including scope, milestones, technical and non-technical deliverables, risks, and dependencies across R&D, manufacturing operations, global supply chain, commercial, quality, clinical, and regulatory.
- Design and lead effective cross-functional program meetings, stand-ups, design reviews, and technical stand-ups; ensure decisions, actions, ownership, and key technical and program details are clearly documented and driven to closure.
- Work with R&D and product management to translate user needs, product requirements, and performance targets into structured program roadmaps and plans.
Drive High-Quality Studies and Documentation- Lead the creation, development, and finalization of key design history file technical documentation including the risk management file, product development requirements, technical protocols and reports for R&D and verification studies, and technical memos.
- Plan, document, and lead feasibility, characterization, verification, and validation studies and supporting activities, ensuring that technical studies (e.g., process verification, biological evaluation, chemical characterization, shelf-life stability, and performance testing) are planned, resourced appropriately, integrated into overall program timelines, and executed on schedule.
Champion Cross-Functional Teamwork and Coordination- Partner with Regulatory and Quality to align NPD program activities, design and development documentation, and risk assessments with quality system requirements and submission strategies, and to ensure readiness for audits.
- Collaborate with Manufacturing Operations and Global Supply Chain to incorporate manufacturing and supply chain requirements in NPD planning.
- Ensure smooth handoff from development to manufacturing transfer, including clear expectations and plans for equipment qualification, process validation, manufacturing transfer, and production ramp-up.
- Continuously collaborate with, communicate with, and educate cross-functional partners on program strategies, plans, and priorities, fostering a culture of strong, energetic cross-functional communication and synergistic teamwork across all functions.
Elevate Program Practices and Outcomes- Identify cross-program and system-level risks, gaps, and opportunities within the LAL NPD portfolio; propose and drive mitigation plans and improvements that enhance product performance, quality, manufacturability, and time-to-market.
- Create and provide clear, concise status updates and dashboards to stakeholders, highlighting accomplishments, upcoming milestones, key decisions, issues, and mitigation plans; adjust plans as needed based on new information and organizational priorities.
- Define and maintain NPD program governance and controls (e.g. phase gates, decision forums, ownership of domains), while maintaining high team empowerment and motivation.
- Track program-level outcomes and benefits (e.g. product performance, cost, quality, time-to-market), ensuring NPD program deliverables remain aligned with business objectives.
- Continuously improve program management practices by collaboratively designing, piloting, and refining scalable, tailormade processes, tools, and templates; proactively identify gaps in how we manage, collaborate, coordinate, and communicate NPD work, and lead cross-functional efforts to close those gaps.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES:- Strong understanding of medical device product development in a regulated environment, including requirements definition, feasibility, verification, validation, manufacturing transfer, and post-market change control.
- Working knowledge of medical device design controls, quality systems, and risk management principles (e.g., 21 CFR Part 820, ISO 13485, ISO 14971), with the ability and willingness to deepen this knowledge on the job.
- Strong analytical and systems-thinking skills, including the ability to interpret test results and program data, identify cross-program trends and risks, and connect findings to product performance, quality, and manufacturability.
- Demonstrated commitment to continuously deepening understanding of LAL technology, its performance characteristics, its manufacturing processes, and its regulatory context and requirements.
- Comfortable operating as both a program leader and technical contributor, moving seamlessly between orchestrating cross-functional work and rolling up sleeves on technical tasks.
- Excellent communication skills including both oral and written formats, with the ability to tailor program and technical information to different audiences (technicians, engineers, leadership, quality, regulatory, and commercial) and drive substantive discussions and decisions.
- Proven ability to coordinate complex, cross-functional technical programs, build practical plans that account for organizational priorities, and ensure on-time completion of critical deliverables in a fast-paced environment.
- Comfortable with project management tools (e.g., Smartsheet, MS Project, or similar) and data/documentation systems (e.g., electronic quality management system, Microsoft Power BI) used to plan, track, and communicate NPD-related work and outcomes.
- Demonstrated skill in facilitating and leading effective, empowering cross-functional meetings and design reviews; able to structure agendas, clarify ownership, resolve ambiguities, and follow through on action items.
- Ability to interface effectively with external partners, including technical consultants, contract manufacturers, test labs, key suppliers, and other development partners, ensuring their activities are managed and integrated into NPD program plans.
- Self-motivated and proactive; able to advance programs effectively with minimal supervision, proactively anticipate and account for risks and gaps, and take initiative to propose and implement program-level improvements.
SUPERVISORY RESPONSIBILITIES:EDUCATION, EXPERIENCE, AND TRAINING:Education- Bachelor's degree in Chemical Engineering, Materials Science, Biomedical Engineering, Chemistry, or a closely related technical discipline required.
- Advanced degree (MS or PhD) in Engineering, Life Sciences, or a related field is a plus but not required.
Experience- Approximately six or more years of progressively responsible experience in medical device product development, project management, program management, quality engineering, R&D engineering, or a closely related discipline.
- 3+ years of direct program or project management responsibility leading cross-functional technical teams from concept through verification/validation and into manufacturing and commercial launch.
- Experience working within structured quality systems and design controls (e.g., 21 CFR 820, ISO 13485), ideally including ownership or coordination of design history file elements.
- Experience coordinating work with external partners (consultants, test labs, or key suppliers) preferred.
- Experience in a small or growing organization, with demonstrated ability to help build or mature processes, is a plus.
- Familiarity with good manufacturing practices (GMP) and good documentation practices (GDP). Experience with good laboratory practices (GLP) is a plus.
Training- PMP, PgMP, or similar project/program management certification is a plus but not required.
- Training or coursework in medical device regulations, design & development, quality systems, risk management, process validation, human factors, and/or similar, is a plus.
CERTIFICATES, LICENSES, REGISTRATIONS:COMPUTER SKILLS:- Proficiency with standard productivity and collaboration tools, including Microsoft Office (Excel, Word, PowerPoint, Visio), Teams, and SharePoint for data analysis, documentation, and cross-functional communication.
- Experience using Business Intelligence software such as Power BI preferred.
- Experience using project and resource management tools (SmartSheet preferred).
- Competence with data analysis and visualization tools (e.g., Excel, Minitab, JMP, or similar) for statistical analysis, trending, and presentation of test results and performance data preferred.
- Familiarity with CAD and drawing tools sufficient to review engineering drawings, understand critical dimensions, and collaborate effectively with design and manufacturing teams (direct, hands-on expertise preferred but not required).
Salary Description
$140,000 To $160,000 Per Year
