DEKA Research & Development

3 days ago

Product Complaints Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 3 hours agoStatus: Live

Job Summary

Review and investigate medical device product complaints to protect patient safety and strengthen the Quality Management System. Conduct complaint evaluations with minimal direction, ensure documentation follows Good Documentation Practices and QMS requirements, and make regulatory reporting decisions under FDA rules and related standards. Partner with manufacturers, healthcare professionals, internal teams, and regulators; support audits/CAPA and forensic investigations; generate improvement reports and training aids.

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: Communications, PR & Community

Key Responsibilities

•Review complaints related to potential medical device issues and perform product complaint evaluations with minimal direction.
•Ensure complaint documentation follows Good Documentation Practices, meets QMS requirements, and complies with FDA regulations and other applicable regulatory requirements.
•Determine and support appropriate medical device reporting to regulatory agencies based on complaint content.
•Interface with third-party manufacturers, healthcare professionals, internal customers, and regulatory agencies; serve as a subject matter expert on complaint handling.
•Participate in audits and CAPA investigations, collaborate with the forensic investigation team, and generate reports and training aids to drive process improvement.

Key Requirements

•Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.
•3-5 years of experience in a regulated medical device, pharmaceutical, or life sciences environment with direct responsibility for complaint investigations and product quality investigations.
•Experience conducting complaint investigations, determining root cause, documenting results, and driving records to closure within established timelines.
•Working knowledge of FDA Quality System Regulations and Medical Device Reporting requirements, including 21 CFR Parts 803 and 820 (ISO 13485 preferred).
•Strong technical writing and communication skills to prepare compliant investigation reports and interact with Quality, Regulatory, Engineering, Manufacturing, Clinical, and Customer Support teams.

Experience:3-5 yearsMedical devicesRegulated industryPharmaceuticalsLife sciences

Education:Bachelor's in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline

Skills:Technical troubleshootingAnalytical thinkingProblem-solvingTime managementTechnical writingCommunicationDetail-orientedSelf-motivatedIndependent decision-making

Tech Stack:SalesforceElectronic quality management systems (eQMS)Complaint handling systems21 CFR Part 80321 CFR Part 820ISO 13485

Company Brief

DEKA Research & Development

DEKA Research & Development is a private R&D and product development firm founded by Dean Kamen that designs and manufactures medical devices, mobility systems, energy and water solutions, and low-volume production prototypes for healthcare and industrial customers.

Industry: Medical Devices

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Manchester, United States

Founded: 1982

Glassdoor: 3.7

Website LinkedIn Glassdoor

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DEKA Research & Development

3 days ago

Product Complaints Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 3 hours agoStatus: Live

Job Summary

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: Communications, PR & Community

Key Responsibilities

•Review complaints related to potential medical device issues and perform product complaint evaluations with minimal direction.
•Ensure complaint documentation follows Good Documentation Practices, meets QMS requirements, and complies with FDA regulations and other applicable regulatory requirements.
•Determine and support appropriate medical device reporting to regulatory agencies based on complaint content.
•Interface with third-party manufacturers, healthcare professionals, internal customers, and regulatory agencies; serve as a subject matter expert on complaint handling.
•Participate in audits and CAPA investigations, collaborate with the forensic investigation team, and generate reports and training aids to drive process improvement.

Key Requirements

•Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline.
•3-5 years of experience in a regulated medical device, pharmaceutical, or life sciences environment with direct responsibility for complaint investigations and product quality investigations.
•Experience conducting complaint investigations, determining root cause, documenting results, and driving records to closure within established timelines.
•Working knowledge of FDA Quality System Regulations and Medical Device Reporting requirements, including 21 CFR Parts 803 and 820 (ISO 13485 preferred).
•Strong technical writing and communication skills to prepare compliant investigation reports and interact with Quality, Regulatory, Engineering, Manufacturing, Clinical, and Customer Support teams.

Experience:3-5 yearsMedical devicesRegulated industryPharmaceuticalsLife sciences

Education:Bachelor's in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related technical discipline

Skills:Technical troubleshootingAnalytical thinkingProblem-solvingTime managementTechnical writingCommunicationDetail-orientedSelf-motivatedIndependent decision-making

Tech Stack:SalesforceElectronic quality management systems (eQMS)Complaint handling systems21 CFR Part 80321 CFR Part 820ISO 13485

Company Brief

DEKA Research & Development

Industry: Medical Devices

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Manchester, United States

Founded: 1982

Glassdoor: 3.7

Website LinkedIn Glassdoor