Head of Manufacturing Science & Technology (MS&T)

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Description

OVERVIEW:

The Head of Manufacturing Science & Technology (MS&T) is the senior technical authority responsible for translating scientifically complex products and processes into robust, scalable, and repeatable manufacturing operations. This role sits at the critical interface between R&D and Manufacturing, with direct accountability for Design for Manufacturing (DFM), process development, overseeing Sustaining Engineering (current and improved processes/equipment) and scale up of production for the Light Adjustable Lens (LAL) intraocular lens platform and its accessories (including lens delivery device and cartridge).

This position is intentionally designed for a leader who remains deeply hands on and technically engaged. The Head of MS&T is expected to work seamlessly across early stage product and process development for new IOL technologies and day to day manufacturing floor support, ensuring that scientific understanding of materials, process physics, and equipment behavior directly informs manufacturing decisions.

The role requires direct involvement in shaping product and process designs to ensure manufacturability, robustness, and long term scalability, and in leading the scale up from development and pilot builds into stable, high volume commercial production of IOLs and their accessories. Success depends on the ability to diagnose and solve complex manufacturing problems at the material, process, and equipment level, while enabling a lean, highly capable technical team to do the same.

The Head of MS&T is expected to remain personally engaged in technical problem solving, providing hands on leadership that ensures manufacturing processes are scientifically sound, operationally stable, and capable of supporting the company's growth while maintaining world class quality and regulatory compliance.

Requirements

Manufacturing Science & Process Development

• Serve as the hands on technical authority for manufacturing processes supporting the IOL and its accessories, with direct involvement in materials, process physics, and equipment behavior.
• Lead and personally engage in process development, characterization, and optimization for material processing, precision molding, assembly, and finishing operations.
• Apply first principles scientific understanding, DOE, SPC, and advanced analytics to diagnose and resolve complex manufacturing issues.
• Drive process robustness, yield improvement, COGS/Gross Margin improvements and scrap reduction through direct technical problem solving, not escalation alone.

Technology Transfer, DFM and Scale-Up

• Co-lead Design for Manufacturing (DFM) activities in close partnership with R&D, ensuring product and process designs are manufacturable, robust, and scalable from inception.
• Maintain direct technical involvement during scale up of the LAL and its accessories, from early development and pilot builds through stable, high volume commercial production.
• Ensure smooth technology transfer by remaining actively engaged during early manufacturing, not operating solely as a transition gate.
• Own manufacturing readiness from a technical risk perspective, ensuring materials, processes, and equipment are production ready.

Manufacturing Engineering & Operational Excellence

• Champion and lead scientific/technical problem solving (involving Manufacturing, Quality, R&D, and Supply Chain) rooted in data, experimentation, and physical understanding.
• Demonstrate true ownership of the production process - comfortable originating proposals, designing a strategy/plan and overseeing through and past implementation
• Ensure validated processes reflect process understanding rather than procedural compliance alone.
• In collaboration with RD&E, guide automation and equipment development with an emphasis on long term process stability and scalability.

Technical Leadership & Team Model

• Define, execute, and own long-term MS&T roadmap that aligns MS&T capabilities with the company's long-term product pipeline, cost structure, and capacity growth objectives.
• Build and lead a lean, highly technical MS&T organization where leaders are expected to remain technically active, engaged and accountable.
• Mentor engineers through direct technical engagement that is curated to specific personalities and skill sets rather than abstract oversight.
• Maintain personal technical credibility across Manufacturing, R&D, Quality, and Regulatory teams through ongoing hands on contribution.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• Deep expertise in polymer chemistry, materials science, physics, or chemical engineering, applied directly to manufacturing processes.
• Demonstrated experience in Design for Manufacturing (DFM) and scaling precision medical devices, including IOLs.
• Proven ability to personally diagnose and solve manufacturing problems at the material-process-equipment interface.
• Strong grounding in DOE, SPC, process characterization, and manufacturing analytics.
• Ability to operate effectively across lab, pilot, and production environments.
• Comfort working in small, technically intense teams with high expectations for individual technical contribution.
• Deep familiarity with FDA 21 CFR 820, ISO 13485, and GMP environments.

SUPERVISORY RESPONSIBILITIES:

• Establish and lead the Manufacturing Science & Technology (MS&T) function as a lean, highly technical organization. Hands on project completion is expected with a "Lead by Example" management style.
• Lead engineers and technical specialists with the expectation of ongoing personal technical engagement.
• Develop technical talent through direct mentorship, experimentation, and hands on problem solving.
• Collaborate closely with Manufacturing, R&D, Quality, Regulatory, and Supply Chain while remaining the primary technical owner of manufacturing process science.

EDUCATION, EXPERIENCE, and TRAINING:

• Bachelor's degree in Materials Science, Polymer Chemistry, Chemical Engineering, or related technical discipline required.
• Advanced degree (MS or PhD) preferred.
• 10 - 15 years of experience in manufacturing, process engineering, or technical operations, preferably in medical devices, pharmaceuticals, biologics, or advanced materials.
• Minimum 5 years leading engineering or technical organizations.
• Experience with Class III regulated medical device manufacturing environments is strongly preferred.
• Training to be completed per the training plan for this position as maintained in the document control system.
• The training requirements on TRN-10007 Insider Trading Policy, TRN-10008 Global Anti-Bribery and Anti-Corruption Policy and TRN-10009 Code of Business Conducts and Ethics must be diligently completed within 30 days from the hiring date and on an annual basis.

CERTIFICATES, LICENSES, REGISTRATIONS:

• N/A

COMPUTER SKILLS:

• MS Office Products
• Experience with manufacturing systems (MES, ERP, and QMS platforms) preferred
• Experience with manufacturing analytics and SPC tools preferred
• Experience with data visualization and reporting tools (e.g., Power BI, Tableau) preferred
• Familiarity with manufacturing control systems and engineering software used in regulated environments preferred.

PERFORMANCE METRICS

• Successful DFM execution and scale up of IOLs and associated accessories
• Established, disciplined, and rapid technology transfer process from R&D to manufacturing
• Manufacturing yield, capacity, and scrap reduction (COGS/Gross Margin improvement)
• Process capability, stability, and validation effectiveness
• Reduction of technical production constraints and recurring process issues

Salary Description

$180,000 To $280,000 Per Year