Manufacturing Engineer

Job Title:

Manufacturing Engineer

Job Description

This Manufacturing Engineer role focuses on process and retrospective validations, quality-driven manufacturing support, and MDR remediation efforts within a regulated medical device environment. You will apply a strong ISO-based quality mindset, execute rigorous validation activities, and maintain high standards of documentation to ensure compliant, efficient, and continuously improving manufacturing processes.

Responsibilities

* Execute process validations, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and retrospective validations for existing processes.

* Support MDR remediation activities by reviewing, updating, and maintaining all related documentation to align with current regulatory expectations.

* Perform statistical data analysis to support validation activities, assess process capability, and identify opportunities for continuous improvement.

* Author, review, and execute validation protocols and reports, ensuring they meet internal standards and regulatory requirements.

* Update and maintain Work Instructions (WIs), Standard Operating Procedures (SOPs), and other manufacturing documentation to reflect current practices and improvements.

* Create, update, and maintain Device Master Records (DMRs) to ensure accurate and complete product and process documentation.

* Collaborate closely with Quality, Manufacturing, and Engineering teams to ensure manufacturing processes comply with applicable medical device regulations and quality system requirements.

* Ensure manufacturing processes meet ISO-based and internal quality standards, and drive adherence to best practices in quality and compliance.

* Support internal and external audits and inspections by providing documentation, explaining processes, and addressing findings related to validation and manufacturing.

* Contribute to cost reduction initiatives by analyzing processes, identifying efficiencies, and implementing validated improvements.

* Drive and support continuous improvement and lean manufacturing activities across manufacturing processes.

* Prepare clear, concise technical reports and documentation to communicate validation outcomes, process changes, and improvement results.

* Participate in cross-functional projects related to process development, process improvement, and manufacturing engineering.

Essential Skills

* 1-4 years of engineering experience in a regulated manufacturing environment.

* Medical device manufacturing experience.

* Working knowledge of ISO-based standards and medical device quality systems.

* Experience with process validation, including IQ/OQ/PQ and retrospective validations.

* Strong understanding of quality principles in a regulated environment.

* Bachelor's degree in Engineering, Manufacturing, Production, or a related science discipline.

* Strong technical writing and documentation skills, including authoring validation protocols, reports, and manufacturing documentation.

* Hands-on experience with process validation and manufacturing documentation.

* Ability to perform statistical data analysis for validation and process capability assessments.

* Experience updating Work Instructions (WIs), SOPs, and production records.

* Demonstrated ability to support MDR remediation activities or similar regulatory-driven documentation updates.

* Proven capability to collaborate with cross-functional teams in Quality, Manufacturing, and Engineering.

Additional

Skills & Qualifications

* Experience supporting MDR remediation projects in a medical device environment.

* Familiarity with FDA medical device regulations and broader medical device regulatory expectations.

* Experience working in a high-volume or precision manufacturing environment.

* in validation data analysis and process improvement initiatives.

* Experience with cost reduction projects in manufacturing.

* Strong report writing and general writing skills for clear technical communication.

* Continuous improvement mindset with experience applying lean manufacturing principles.

* Knowledge of Six Sigma methodologies and tools.

* Experience in manufacturing process development and process improvement.

* Exposure to Solid Works or similar engineering design tools.

* Experience with machining, assembly, automation, and production environments.

* Project management skills for coordinating validation and improvement activities.

* Broad experience in manufacturing engineering and validation within regulated industries.

Work Environment

The role operates within a regulated medical device manufacturing environment that emphasizes rigorous quality standards, robust documentation, and compliance with ISO-based quality systems and medical device regulations. You will work closely with cross-functional teams in Quality, Manufacturing, and Engineering, often in a production setting that may be high-volume or precision-focused. The environment supports structured validation activities, continuous improvement…