Job SummaryThe Manufacturing Engineer works closely with Operations, Quality, R&D, and cross-functional teams to lead process engineering, continuous improvement, and new product introduction (NPI) manufacturing readiness efforts. This role serves as the technical focal point for manufacturing processes, applying Lean Six Sigma methodologies, statistical tools, and structured problem-solving to optimize production efficiency, reduce waste, ensure regulatory compliance, and drive measurable improvements across the manufacturing floor. The Manufacturing Engineer is responsible for process development, validation, documentation, and sustaining engineering activities in support of existing and new products in a GMP medical device environment.
Essential Functions- Develop, own, and maintain Process Failure Mode and Effects Analysis (pFMEA) and Control Plans to proactively identify and mitigate process risks throughout the product lifecycle.
- Lead and execute process qualification activities including IQ, OQ, and PQ protocols.
- Plan and conduct validation runs and Gage R&R studies to ensure measurement system and process capability.
- Support driving BOM creation, product drawings, engineering change control and dimensional inspection criteria.
- Lead root cause and corrective action (RCCA) investigations using structured methodologies (e.g., fishbone diagrams, 5-Whys); author and close CAPAs and NCRs in compliance with regulatory requirements.
- Develop and maintain process flow diagrams, SOPs, and work instructions; ensure all process documentation is accurate, current, and aligned with GMP standards and applicable regulatory requirements.
- Support NPI manufacturing readiness activities including process development, process flow design, costing structure, and capacity modeling to ensure a successful production ramp.
- Evaluate and improve quality control processes; analyze production data and SPC charts, assess process capability (Cpk), and provide management with data-driven reports and statistical summaries to support informed decision-making.
- Analyze and optimize workflow, equipment placement, and space requirements to improve manufacturing efficiency; conduct time studies and process analyses to identify bottlenecks and implement solutions.
- Support design verification testing and perform process verification/validation.
- Review and calculate labor, material, and production costs; develop standard labor-based costing structures and review production schedules and future capacity requirements to assist management in resource and planning decisions.
- Coordinate and schedule equipment preventative maintenance; ensure manufacturer procedures and service instructions are followed to maintain production equipment in qualified operating conditions.
- Ensure manufacturing processes are in compliance with applicable regulations and industry standards; support internal and external audits and drive remediation efforts as needed.
- Read and interpret 2D and 3D engineering drawings, blueprints, and models to support process design, tooling assessment, and manufacturing feasibility reviews.
- Develop and maintain positive cross-functional relationships with Operations, Quality, R&D, and other teams; provide process engineering expertise to support product improvements, complaint investigations, and continuous improvement initiatives.
- Perform other duties as assigned.
Education- Bachelor's degree in Mechanical Engineering, Industrial Engineering, or another related STEM field.
Required Experience & Competencies- 5+ years of hands-on manufacturing engineering experience in a medical device, pharmaceutical, or regulated manufacturing environment.
- Demonstrated proficiency with Lean Six Sigma tools including Value Stream Mapping, SPC, Cpk, time studies, capacity modeling, and Kaizen; Green Belt or Black Belt certification preferred.
- Experience authoring and executing IQ/OQ/PQ protocols, validation runs, and Gage R&R studies; familiarity with process qualification requirements in a GMP environment.
- Solid understanding of pFMEA, Control Plans, and process risk management methodology; change control and documentation experience in a regulated quality system.
- Proficient in structured root cause and corrective action methodologies (RCCA); experience authoring, tracking, and closing CAPAs and NCRs.
- Ability to read and interpret 2D and 3D engineering drawings, blueprints, and CAD models in support of process design and tooling assessments.
- Experience developing and maintaining SOPs, work instructions, process flow diagrams, and other GMP-compliant manufacturing documentation.
- Self-starter with strong project management skills; able to manage multiple priorities independently with minimal supervision.
- Strong verbal and written communication skills; ability to effectively interact with personnel at all levels and present data-driven findings to management.
- Experience working in a GMP manufacturing or regulated laboratory environment; familiarity with applicable FDA, ISO 13485, and other relevant regulatory standards.
- Able to travel up to 10%.
Preferred Experience- NPI manufacturing readiness experience including process development, capacity modeling, and standard labor cost structure development.
- Process characterization experience applying Design of Experiments (DOE) to optimize manufacturing processes.
- Experience in single-use consumable or bioprocessing device manufacturing environments.
- Familiarity with equipment preventative maintenance scheduling and coordination in a manufacturing setting.
- Detail and deadline oriented; well organized with the ability to work cross-functionally and independently to solve problems.
