Director of Manufacturing Engineering

Job Summary

The Director of Manufacturing Engineering combines deep technical expertise with cross-functional leadership to ensure the successful industrialization, optimization, and scalability of products and processes within SaniSure Operations. This individual will lead teams in process development, tooling, automation, industrialization of new products, and continuous improvement initiatives to deliver sustainable cost reductions, quality improvements, and operational excellence. The role also owns capital equipment strategy, design for manufacturability, risk management, and engineering documentation while maintaining compliance with regulatory and quality standards.

Essential Functions

Manufacturing Process & Product Industrialization

• Lead engineering efforts in the industrialization of new products, process optimization, and cost-reduction initiatives.
• Oversee development and documentation of manufacturing processes, including PFMEAs, control plans, process flow diagrams, SOPs, and work instructions.
• Collaborate with R&D and Design Engineering to integrate Design for Manufacturability (DFMA) and Design to Cost (DTC) early in the product lifecycle.
• Lead efforts in capital equipment specification, procurement, installation, and qualification (IQ/OQ/PQ).
• Champion the application of Lean, Six Sigma, DOE, and SPC tools to reduce variability, improve yields, and drive efficiency.
• Own and oversee implementation of process validation strategies.

Technical Leadership & Equipment Strategy

• Lead the evaluation, standardization, and deployment of advanced manufacturing technologies, automation solutions, and plastic processing.
• Specify and qualify capital equipment; conduct ROI analysis and manage lifecycle planning.
• Drive process harmonization across multiple manufacturing lines and facilities.

Team Leadership & Development

• Lead, mentor, and develop a high-performing engineering team, including Manufacturing Engineers, Process Engineers, and Technicians.
• Set departmental objectives and KPIs aligned with business strategy; coach team members to achieve results.
• Support performance management, talent development, and succession planning.
• Foster a culture of safety, collaboration, innovation, and accountability.

Cross-Functional Collaboration

• Partner with Quality, Operations, Supply Chain, and Customer Service to troubleshoot production issues and drive corrective/preventive actions (CAPA’s).
• Support Design Engineering in managing technical drawing reviews, BOM accuracy, and CAD standardization.
• Represent engineering in key project meetings, audits, and customer discussions as needed.

Documentation, Compliance & Systems

• Ensure all technical documentation meets regulatory, quality, and internal standards.
• Maintain engineering data integrity across ERP and PDM systems (SyteLine experience preferred).
• Author or review key documentation such as SOPs, cleaning procedures, equipment setup/changeover sheets, and validation protocols.

• Ensure compliance with GMP, ISO, OSHA, and internal quality system requirements.
• Other duties as assigned

Education & Experience

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, Biomedical, or related Engineering field.
• Master’s degree preferred.
• 10 years of progressive engineering experience in a regulated manufacturing environment.
• 5 years in a formal leadership role managing engineering teams across functions or geographies.
• Demonstrated success in industrializing new products, leading process improvements, and managing capital projects.
• Strong background in plastic component design, tooling, and manufacturing.
• Hands-on experience with CAD tools (SolidWorks preferred) and familiarity with ERP/PDM systems.
• Expert in PFMEA, process validation, and change control.
• Skilled in lean manufacturing, value stream mapping, 5S, and root cause analysis.
• Proficient in statistical analysis, DOE, and SPC techniques.
• Strong project management skills and ability to manage multiple priorities.
• Deep understanding of manufacturing cost models, labor standards, and process efficiency metrics.
• Effective communicator—verbal, written, and visual—with strong interpersonal and influencing skills.
• High sense of urgency and bias for action in a fast-paced environment.
• Ability to lead cross-functional teams and drive cross-departmental initiatives to completion.
• Lean Six Sigma Green Belt or Black Belt.
• Experience with single-use consumables, bioprocessing, or biotech devices.
• Familiarity with validation and documentation within GMP/ISO environments.
• Experience working with multiple bioprocessing equipment suppliers and configurations.