Senior Manufacturing Process Engineer

SUMMARY Manufacturing Engineer with strong process engineering and project management capability to drive manufacturing excellence, product scalability, and operational efficiency. This role emphasizes Lean principles, process optimization, and disciplined execution across the full product lifecycle—from design transfer through sustained production—while leading cross-functional teams to deliver results.

ESSENTIAL DUTIES

Process Engineering & Continuous Improvement Design, develop, and optimize manufacturing processes (assembly, automation, packaging) Lead Lean initiatives (waste reduction, flow improvement, standard work, visual management) Apply tools such as Value Stream Mapping (VSM), Kaizen, 5S, and root cause analysis Improve throughput, reduce cycle time, and stabilize processes (SPC, Cp/Cpk) Own process validation activities (IQ/OQ/PQ) and ongoing process capability monitoring Project / Program Management Lead cross-functional projects/programs tied to process improvements, NPI, and capacity expansion Develop and manage detailed project plans (scope, schedule, cost, risks) Drive execution against milestones with clear accountability and communication Manage change control (ECR/ECO) and ensure alignment with quality and regulatory requirements Cross-Functional Leadership Lead and influence teams across R&D, Quality, Operations, Supply Chain, and Commercial functions Align stakeholders on priorities, trade-offs, and execution plans without direct authority Facilitate structured decision-making and ensure clear ownership of actions and deliverables Drive accountability and maintain momentum across multiple concurrent initiatives Manufacturing & Operations Integration Partner with Operations to ensure efficient production flow and constraint management Support capacity planning, line balancing, and labor optimization Implement pull systems, WIP controls, and inventory optimization strategies Collaborate with Supply Chain on supplier performance and material flow Design for Manufacturability (DFM) Provide early input into product design to ensure manufacturability and scalability Drive design improvements that reduce cost, complexity, and variability Support transition from R&D to production (NPI, pilot builds, ramp-up)

KNOWLEDGE, SKILLS, AND ABILITIES

Engineering & Technical Process design/optimization (assembly, automation, packaging) Design for Manufacturability (DFM), Design for Assembly (DFA), Geometric Dimensioning & Tolerancing (GD&T), tolerance analysis, material selection CAD (SolidWorks or similar); tooling/fixture design Validation (IQ/OQ/PQ) and test method development Design of Experiment and basic statistical analysis Process Excellence & Lean Lean tools (VSM, Kaizen, 5S, standard work) Statistical Process Control (SPC), Process Capability (Cp), Process Capability Index (Cpk) Line balancing, capacity/constraint management Problem Solving & Quality Root cause analysis (5 Whys, Fishbone), PFMEA CAPA and risk management Experience in regulated/QMS environments preferred Project & Leadership Project/program management (scope, schedule, risk) Cross-functional leadership and stakeholder alignment Systems & Data ERP/MRP (e.g., D365) Data analysis tools (Excel, Minitab) Strong documentation and change control discipline Success Metrics Reduction in cycle time and WIP Improvement in throughput and on-time delivery (OTIF) Increased process capability (Cp/Cpk) and reduced variability Successful NPI and design transfer to production Measurable cost reductions (labor, scrap, COGS) Strong cross-functional alignment and execution across teams

QUALIFICATIONS / REQUIREMENTS

Bachelor's degree in mechanical engineering or related field 7-12 years of manufacturing engineering experience Medical device or regulated industry experience Lean Six Sigma certification PMP certification or equivalent experience preferred Experience with ERP systems (e.g., Microsoft Dynamics 365) Experience with automation and equipment integration Familiarity with Factory Physics concepts (flow, WIP, constraint management)

WORKING CONDITIONS

The physical demands and work environment described below represent the activities and surroundings of the positions. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Prolonged periods sitting at a desk and working on a computer. Must be able to lift up to 15 pounds at times. Who We Are The Solmetex family of brands is transforming dental practice safety and efficiency. Our portfolio — Solmetex, Sterisil, DryShield, ReLeaf, and Impladent — delivers solutions that manage water and infection control, improve patient care, and help practices stay compliant with safety regulations. We're innovators and problem-solvers , developing advanced dental technologies that meet rigorous standards like U.S. FDA, EPA, NSF, and EU MDR . From waterline treatment to evacuation and isolation systems, our brands provide integrated solutions that make dental practices safer, cleaner, and more efficient. At Solmetex, we're proud of our culture of growth, collaboration, and environmental responsibility . Join us, and you'll be part of a team shaping the future of dental care — building products that protect patients, staff, and the planet. We offer competitive salaries, medical/dental/vision coverage, company-paid life insurance and long-term disability, a 401(k) with Safe Harbor matching, and generous paid time off . No relocation or sponsorship assistance available.