Manufacturing Engineer

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.

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.

Essential Skills

+ Bachelor's degree in Engineering or a related technical field.

+ 5+ years of experience in a regulated manufacturing environment, preferably in medical devices.

+ 2+ years of experience specifically as a Manufacturing Engineer.

+ Working knowledge of FDA Quality System Regulation (QSR).

+ Working knowledge of ISO 13485:2016 or similar medical device quality management standards.

+ Working knowledge of EU MDR (2017/745) requirements.

+ Hands-on experience with process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

+ Experience conducting non-conformance investigations, including root cause analysis and implementation of CAPA.

+ Strong understanding of statistical process control (SPC) and process improvement methodologies.

+ Proficiency with Solid Works for engineering design and documentation.

+ Proficiency with Microsoft Office applications, including Excel and Word.

+ Experience in process improvement initiatives and change order processes within a manufacturing environment.

+

Experience with manufacturing processes and equipment used in regulated environments, including equipment validation and reliability-focused…