Manufacturing Engineer

Job Title:

Manufacturing Engineer

Job Description

This role offers an opportunity for an experienced Manufacturing Engineer to drive compliance, quality, and efficiency in medical device manufacturing. You will focus on ensuring manufacturing processes meet EU Medical Device Regulation (EU MDR 2017/745) requirements and applicable quality and regulatory standards. The position centers on assessing, remediating, validating, and documenting manufacturing processes, while collaborating closely with Quality, Regulatory Affairs, R&D, Operations, and Supply Chain teams.

You will lead process improvements, risk management activities, and technical documentation efforts to support ongoing regulatory compliance and robust manufacturing performance in a highly regulated environment.

Responsibilities

+ Support EU MDR compliance initiatives for legacy medical device products by reviewing and aligning existing manufacturing processes and documentation with current regulatory expectations.

+ Assess manufacturing processes against EU MDR requirements and identify compliance gaps, deficiencies, and areas for improvement.

+ Execute remediation activities to address manufacturing process deficiencies identified through MDR assessments, audits, inspections, and internal reviews.

+ Ensure manufacturing documentation aligns with EU MDR, applicable quality system regulations, and relevant regulatory requirements.

+ Support the preparation, review, and maintenance of Technical Documentation and Design Transfer documentation for medical device products.

+ Lead remediation projects for manufacturing processes impacted by MDR requirements, ensuring timely completion and sustained compliance.

+ Review and update manufacturing work instructions, process specifications, manufacturing procedures, and quality documentation to reflect current practices and regulatory requirements.

+ Assess existing process controls and implement improvements to ensure consistent product quality, process robustness, and regulatory compliance.

+ Collaborate with cross-functional teams, including Quality, Regulatory Affairs, R&D, Operations, and Supply Chain, to resolve process nonconformities and close compliance gaps.

+ Develop, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and processes.

+ Create and execute process validation protocols and reports, including manufacturing process verifications and equipment qualifications.

+ Analyze validation data, apply appropriate statistical methods, and provide statistically sound conclusions and recommendations.

+ Ensure all validation and verification activities meet regulatory, quality, and customer requirements.

+ Lead the creation, remediation, and maintenance of Process Failure Mode and Effects Analyses (PFMEA), control plans, and process risk assessments.

+ Ensure PFMEAs align with process validation activities, production controls, and overall risk management strategies.

+ Support risk management activities in compliance with relevant ISO standards for medical devices.

+ Apply strong troubleshooting and root cause investigation skills to resolve process issues and prevent recurrence.

+ Manage multiple remediation and improvement projects simultaneously, balancing priorities and timelines in a fast-paced environment.

+ Communicate effectively with stakeholders at all levels, providing clear updates, documentation, and technical justifications for process changes and validation outcomes.

Essential Skills

+ Bachelor's degree in Engineering, such as Manufacturing, Mechanical, Biomedical, Industrial, Chemical, or a related discipline.

+ Minimum of 3 years of manufacturing engineering experience in a regulated medical device environment.

+ Demonstrated experience with EU MDR (2017/745) compliance activities, particularly as they relate to manufacturing processes and documentation.

+ Experience performing manufacturing process remediation to support regulatory compliance initiatives.

+ Strong experience developing and executing process validations, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

+ Experience conducting process verification activities to confirm process performance and capability.

+ Experience developing and executing equipment qualification protocols and authoring validation reports.

+ Proven experience creating, updating, and remediating Process Failure Mode and Effects Analyses (PFMEAs) and process risk assessments.

+ Working knowledge of medical device quality system regulations, including 21 CFR Part 820.

+ Understanding of Good Manufacturing Practice (GMP) requirements in a medical device context.

+ Experience supporting regulatory audits and inspections, including preparation, on-site support, and follow-up actions.

+ Strong technical writing and documentation skills, with the ability to produce clear, complete, and compliant records and reports.

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