Manufacturing Engineer - Medical Device

Job Title:

Manufacturing Engineer

Job Description

This role supports and improves manufacturing operations for regulated medical device products, with a strong focus on process efficiency, product quality, and regulatory compliance. The Manufacturing Engineer works closely with production, quality, and R&D teams to troubleshoot issues, implement process improvements, and support new product introduction from design through validation and full-scale manufacturing.

Required:

+ Bachelor's degree in Engineering

+ 5+ years in regulated manufacturing (medical device preferred)

+

Experience with process validation (IQ/OQ/PQ)

+

Experience with CAPA, root cause analysis, and non-conformance investigations

+ Knowledge of FDA QSR and/or ISO 13485

+ Experience supporting NPI and process improvements

+ Proficiency with Solid Works and Microsoft Office

Preferred:

+

Experience with EU MDR

+ ERP or QMS system experience

Responsibilities

+ Provide day-to-day engineering support to production and product development teams to ensure stable, efficient, and compliant manufacturing operations.

+ Develop, optimize, and improve manufacturing processes, tooling, and equipment to enhance product quality, increase throughput, and reduce costs.

+ Troubleshoot and resolve production issues related to processes, equipment, and methods, ensuring minimal disruption to manufacturing schedules.

+ Lead and support process validation activities (IQ, OQ, PQ) for new and existing equipment and processes in accordance with regulatory and internal quality requirements.

+ Investigate non-conformances, perform root cause analysis, and drive effective corrective and preventive actions (CAPA) to prevent recurrence.

+ Create, maintain, and update manufacturing documentation, including specifications, work instructions, and document change requests (DCRs) and change orders.

+ Support new product introduction (NPI) and the transfer of products and processes from R&D into full-scale production, ensuring manufacturability and compliance.

+ Partner with Quality to improve inspection methods, measurement techniques, and control plans to ensure adherence to internal and external quality standards.

+ Create, implement, and monitor statistical process control (SPC) charts and other process metrics to drive consistency, identify trends, and support continuous improvement.

+ Assist with preventative maintenance planning and equipment support to improve equipment reliability and uptime.

+ Support equipment validation and equipment maintenance activities in alignment with quality and regulatory expectations.

+ Collaborate with supply chain and sourcing functions to support supplier qualification and address supplier-related issues, including long lead time components.

+ Contribute to process improvement and continuous improvement initiatives across the manufacturing operation, including document change orders and process change requests.

+ Train production personnel on new or updated processes, equipment, and documentation to ensure proper understanding and consistent execution.

+ Support quality management system (QMS) activities and documentation, including use of electronic QMS tools, to maintain a robust and compliant quality system.

+ Engage in fast-paced problem-solving activities, quickly assessing issues on the manufacturing floor and implementing effective short-term and long-term solutions.

Work Environment

This position is based 100% onsite in a highly regulated manufacturing facility producing medical device products for optometric eye care. The environment is fast-paced and collaborative, with frequent interaction among production, quality, and R&D teams. The role requires a strong, hands-on presence on the manufacturing floor, where issues may arise unexpectedly and must be addressed quickly and systematically. The facility operates under strict FDA QSR, ISO 13485:2016, and EU MDR requirements, supported by formal quality management and ERP systems.

The culture emphasizes problem-solving, continuous improvement, and close teamwork to maintain high product quality and reliable operations.

Job Type & Location

This is a Contract to Hire position based out of…