Sr. Manufacturing Engineer

Job Description

Job Description

Position Summary

The Senior Manufacturing Engineer, Advanced Processes serves as a technical leader supporting the development, validation, optimization, and commercialization of complex medical device manufacturing processes. This role provides engineering leadership for advanced manufacturing processes, automation, tooling development, process validation, and manufacturing scale-up activities.

 

The ideal candidate combines strong hands-on manufacturing engineering capability with practical knowledge of tooling, automation, process validation, and regulated medical device manufacturing. This position works closely with Operations, Quality, Maintenance, Supply Chain, and Sales to support both existing production and new business opportunities.

 

This is a highly collaborative, floor-focused engineering role requiring strong technical judgment, problem solving, and communication skills.

 

Essential Responsibilities

• Provide technical leadership for manufacturing processes including RF welding, flexible materials manufacturing, and related assembly operations.
• Develop, optimize, validate, and sustain manufacturing processes with focus on safety, quality, throughput, repeatability, and cost.
• Design and improve tooling, fixtures, manufacturing equipment, and automation systems to support production and new product introduction activities.
• Lead process validation activities including development and execution of IQ/OQ/PQ protocols, manufacturing specifications, process documentation, and related validation records.
• Troubleshoot manufacturing, process, equipment, and quality issues while driving effective corrective actions and continuous improvement initiatives.
• Support commercialization of new products through design-for-manufacturing (DFM) assessments, process development, equipment selection, production readiness activities, and creation of manufacturing documentation and ERP master data.
• Translate customer specifications and product requirements into internal manufacturing documentation including bills of materials, routers, work instructions, manufacturing specifications, and ERP master data.
• Partner with Sales and customers to support technical evaluations, manufacturability reviews, quoting activities, and new business opportunities.
• Lead manufacturing transfer activities between development and production sites, including process documentation, training, startup support, and standardization efforts.
• Lead cross-functional efforts with Operations, Quality, Maintenance, Supply Chain, and external suppliers to support manufacturing objectives.
• Mentor technical personnel and serve as subject matter expert for assigned manufacturing processes and technologies.
• Perform other related duties as assigned.
• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related technical discipline. Equivalent practical experience may be considered.
• Minimum 6 years of manufacturing engineering experience within a regulated industry environment. Medical device manufacturing experience strongly preferred.
• Experience supporting validated manufacturing processes within FDA and/or ISO 13485 regulated environments.
• Strong understanding of cGMP requirements, Good Documentation Practices, and medical device validation methodologies.
• Demonstrated experience writing and executing validation protocols including IQ/OQ/PQ.
• Strong hands-on experience with tooling, fixturing, machining, fabrication, and equipment troubleshooting.
• Experience supporting automated manufacturing equipment, PLC-controlled systems, sensors, motion systems, or industrial automation technologies.
• Proficiency with CAD software including SolidWorks and AutoCAD or equivalent systems.
• Ability to read and interpret engineering drawings, mechanical assemblies, and technical specifications.
• Strong analytical and problem-solving skills with ability to independently drive technical solutions.
• Excellent communication skills with ability to interact effectively with manufacturing personnel, customers, suppliers, auditors, and cross-functional teams.
• Comfortable operating in a hands-on manufacturing environment with direct interaction with production equipment and manufacturing operations.
• Experience with RF welding, heat sealing, flexible materials manufacturing, bagmaking, converting, extrusion, or related polymer processing technologies.
• Experience supporting automated manufacturing equipment, motion control systems, sensors, PLC-controlled equipment, or industrial automation projects.
• Experience with tooling design, machining, fabrication, and equipment integration.
• Experience supporting manufacturing transfer, process scale-up, or multi-site production environments.
• Experience supporting customer-facing technical discussions, commercialization efforts, or manufacturing cost estimation and quoting activities.
• Experience creating and maintaining ERP manufacturing data including bills of materials, routers, item masters, and manufacturing specifications.
• Lean Manufacturing and continuous improvement experience.
• Project management experience supporting capital equipment, process development, or new product introduction initiatives.
• Bilingual English/Spanish communication skills are a plus.

  MINIMUM QUALIFICATIONS

Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related technical discipline. Equivalent practical experience may be considered.

• Minimum 6 years of manufacturing engineering experience within a regulated industry environment. Medical device manufacturing experience strongly preferred.
• Experience supporting validated manufacturing processes within FDA and/or ISO 13485 regulated environments.
• Strong understanding of cGMP requirements, Good Documentation Practices, and medical device validation methodologies.
• Demonstrated experience writing and executing validation protocols including IQ/OQ/PQ.
• Strong hands-on experience with tooling, fixturing, machining, fabrication, and equipment troubleshooting.
• Experience supporting automated manufacturing equipment, PLC-controlled systems, sensors, motion systems, or industrial automation technologies.
• Proficiency with CAD software including SolidWorks and AutoCAD or equivalent systems.
• Ability to read and interpret engineering drawings, mechanical assemblies, and technical specifications.
• Strong analytical and problem-solving skills with ability to independently drive technical solutions.
• Excellent communication skills with ability to interact effectively with manufacturing personnel, customers, suppliers, auditors, and cross-functional teams.
• Comfortable operating in a hands-on manufacturing environment with direct interaction with production equipment and manufacturing operations.

Preferred Qualifications

• Experience with RF welding, heat sealing, flexible materials manufacturing, bagmaking, converting, extrusion, or related polymer processing technologies.
• Experience supporting automated manufacturing equipment, motion control systems, sensors, PLC-controlled equipment, or industrial automation projects.
• Experience with tooling design, machining, fabrication, and equipment integration.
• Experience supporting manufacturing transfer, process scale-up, or multi-site production environments.
• Experience supporting customer-facing technical discussions, commercialization efforts, or manufacturing cost estimation and quoting activities.
• Experience creating and maintaining ERP manufacturing data including bills of materials, routers, item masters, and manufacturing specifications.
• Lean Manufacturing and continuous improvement experience.
• Project management experience supporting capital equipment, process development, or new product introduction initiatives.
• Bilingual English/Spanish communication skills are a plus.