Product Complaints Engineer

DEKA Research & Development•Manchester, NH

About The Position

DEKA R&D, on behalf of Millyard Advanced Medical Products, is seeking a Product Complaints Engineer for a dynamic medical device research and development environment. The position reports to the Product Complaints Manager and has a high-visibility role with a significant direct impact on the Quality Management System. The engineer reviews and evaluates complaints concerning potential medical device issues, ensuring investigations and documentation comply with Good Documentation Practices, QMS requirements, FDA regulations, and other applicable regulatory requirements. The role involves assessing reportability, coordinating with internal and external stakeholders, participating in audits and CAPA investigations, and working with the forensic investigation team. The engineer also generates process-improvement reports, develops product training aids, contributes as an independent subject matter expert, and collaborates across teams and departments.

Requirements

Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.
Minimum of 3–5 years of experience in a regulated medical device, pharmaceutical, or life sciences environment, with direct responsibility for complaint investigations, product quality investigations, product analysis, and complaint closure activities.
Demonstrated experience conducting complaint investigations, determining root cause, documenting investigation results, and independently driving records to closure in compliance with established timelines.
Working knowledge of FDA Quality System Regulations, Medical Device Reporting requirements, and applicable standards, including 21 CFR Parts 803 and 820.
Strong technical troubleshooting, analytical, and problem-solving skills, including assessing complex product performance issues and identifying potential failure modes.
Excellent time management skills and ability to manage a high-volume complaint workload while meeting regulatory and internal closure targets.
Excellent technical writing skills and demonstrated ability to prepare clear, concise, and compliant investigation reports.
Strong written and verbal communication skills and ability to interact effectively with Quality, Regulatory, Engineering, Manufacturing, Clinical, and Customer Support teams.
Highly organized, detail-oriented, and self-motivated, with ability to work independently and make evidence-based decisions.
Ability to thrive in a fast-paced, changing environment while maintaining compliance with regulations, procedures, and quality system requirements.

Nice To Haves

Experience with ISO 13485.
Experience evaluating product complaints for reportability and supporting regulatory submissions.
Experience using electronic quality management systems (eQMS), complaint handling systems, and platforms such as Salesforce.

Responsibilities

Review complaints related to potential medical device issues.
Perform product complaint evaluations with minimal direction, using experience and product knowledge.
Ensure complaint documentation follows Good Documentation Practices, meets QMS requirements, and complies with FDA and other regulatory requirements.
Identify and make sound decisions regarding medical device reporting to regulatory agencies.
Interface with Third Party Manufacturers, health care professionals, internal customers, and regulatory agencies.
Participate in audits and CAPA investigations related to complaint handling.
Work with the forensic investigation team to align product investigations related to complaints.
Generate reports to identify areas of process improvement.
Develop product training aids.
Contribute independently and collaborate with team members and departments needing product complaint information.
Maintain positive and cooperative communication with co-workers, customers, contractors, and vendors.
Serve as a subject matter expert on complaint handling.
Perform other related duties as assigned under management supervision.