Job Description:

JOB SUMMARY:

The Director, Manufacturing Process Development will develop, characterize, scale, validate, transfer, and optimize manufacturing processes for dental consumables globally. This role translates product, chemistry, material, quality, and customer requirements into robust, compliant, cost-effective manufacturing processes within an FDA- and ISO-regulated environment.

Reporting to the VP, Innovation & R&D, this leader bridges R&D Engineering, Manufacturing, Regulatory Affairs, Supply Chain, and Procurement, driving manufacturing readiness, technical risk management, and process ownership. The role leads a team of engineers and requires strong influence, relationship-building, and cross-functional navigation skills.

Candidate must reside within a commutable distance to Pomona, CA. This is not a hybrid or remote opportunity and requires onsite presence 4 days per week.

PRIMARY DUTIES & RESPONSIBILITIES:

• Develop process development strategy and roadmaps aligned to business and portfolio priorities, setting standards, governance, and resourcing for development, scale-up, validation, and lifecycle support.
• Lead, coach, and develop a process engineering team, building technical depth, accountability, and succession planning.
• Develop scalable manufacturing platforms, standards, and reusable process technologies to accelerate future product introductions and operational excellence.
• Drive development and adoption of innovative manufacturing technologies and automation solutions to improve scalability, quality, efficiency, and competitive advantage.
• Partner with product development teams to embed design-for-manufacturability principles early in product and formulation development.
• Own process development from feasibility through validation and transfer for adhesives, composites, cements, endodontic, and other dental consumable platforms, defining process specifications, critical parameters, and controls.
• In collaboration with Chemistry team, characterize material and process behavior (e.g., rheology, mixing, variability, hold times) to build scientific understanding linking materials, equipment, and finished-product performance.
• Apply Design of Experiments (DOE), statistical analysis, and risk-based tools to define process design spaces, control strategies, and acceptance criteria.
• Identify, assess, and mitigate manufacturing, scale-up, and commercialization risks throughout the product lifecycle.
• Lead pilot builds, scale-up, qualification, validation, and manufacturing transfer, ensuring readiness criteria, documentation, and training are in place.
• Provide process development leadership on New Product Development (NPD), commercialization, and lifecycle teams, aligning scope, risk, resources, and timelines across functions.
• Serve as the key technical liaison between Manufacturing and R&D, building trust and alignment across functions without relying on positional authority.
• Partner with Operations and Engineering to optimize processes, troubleshoot issues, and improve capability across the product lifecycle, clarifying handoffs from development to routine manufacturing.
• Collaborate on investigations into nonconformances, deviations, and quality events using root-cause analysis and statistical methods to drive effective CAPAs.
• Define equipment and process requirements and partner with cross-functional teams and vendors on selection, integration, and automation to improve safety, quality, and efficiency.
• Drive measurable improvements in yield, throughput, cycle time, capability, and cost through continuous improvement initiatives.
• Ensure all activities comply with the Quality Management System (QMS), FDA requirements, ISO 13485, GMP, EH&S, and applicable SOPs; support audits, CAPAs, and regulatory submissions.
• Communicate strategy, readiness, risk, and outcomes to senior leadership, ensuring sound documentation and escalation practices.
• Travel approximately 25% domestically and internationally to support manufacturing sites.

Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and additional responsibilities may be assigned, as required, by management.

Job Requirements:

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. This individual must be able to function in a fast-paced environment where priorities may change rapidly. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

REQUIREMENTS:

• Bachelor’s degree in Chemical Engineering, Materials Science, Polymer Science, Chemistry, Biomedical Engineering, Manufacturing Engineering, or a related discipline required; master’s degree or PhD preferred.
• 10+ years of progressive experience across developing, scaling, or validating manufacturing processes in a regulated or formal quality-system environment is required.
• 5+ years of people and cross-functional leadership experience required.
• Experience in supporting multi-site or global manufacturing operations preferred.
• Experience with Lean manufacturing or Six Sigma tools and/or methodologies required.

SKILLS/ABILITIES:

• Demonstrated ability to influence without authority, gain commitment, and lead through relationships, technical credibility, data, and shared business objectives required.
• Exceptional relationship-building and collaboration skills, with a demonstrated ability to create alignment and trust between Manufacturing and R&D required.
• Strong people leadership skills with a record of developing technical talent, building capability, setting clear expectations, and driving accountability required.
• Advanced problem-solving and analytical skills, including Design of Experiments (DOE), statistical analysis, process capability, root-cause analysis, and risk-based decision making required.
• Demonstrated ability to lead complex programs, prioritize resources, manage ambiguity, resolve conflict, and drive execution across functions and sites required.
• Strong business and operational acumen, including the ability to balance safety, quality, compliance, delivery, innovation, capacity, and cost required.
• Strong verbal, presentation, facilitation, and technical writing skills in English, with the ability to communicate effectively from the manufacturing floor through executive leadership required.

PREFERRED QUALIFICATIONS:

• Experience working with formulated medical-device products preferred.
• Ability to build business cases and use data to support equipment, automation, process technology, capacity, and cost-improvement investments preferred.
• Intermediate Microsoft Office skills, including Outlook, Word, Excel, and PowerPoint, required; proficiency with statistical analysis software and aptitude to learn enterprise systems preferred.

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.  At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

Operating Company: