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 activities.

* Experience working within a formal quality management system in a highly regulated industry.

Additional

Skills & Qualifications

* Experience with ERP systems; specific platforms are a plus, but any ERP experience is acceptable.

* Exposure to electronic quality management systems (QMS), such as Qualio or similar tools.

* Experience supporting supplier qualification and addressing sourcing or supply chain issues.

* Exposure to the end-to-end product lifecycle, from design through validation and manufacturing.

* Experience working with international suppliers and managing challenges related to long lead times.

* Background in medical device manufacturing or other highly regulated industries.

* Experience with continuous improvement initiatives, including process optimization and documentation updates.

* Familiarity with…