DEKA Research & Development

3 days ago

Product Complaints Engineer - Team Lead

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 2 hours agoStatus: Live

Job Summary

Lead a small team of Product Complaints Engineers in a medical device environment, reviewing and evaluating device-related complaints with minimal direction. Own compliant complaint documentation within the Quality Management System (QMS) and ensure medical device reporting decisions meet U.S. FDA requirements. Collaborate across teams, interface with manufacturers and healthcare professionals, support audits and CAPA investigations, and help improve complaint handling through training, procedures, and work instructions.

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: Administration & Executive Assistance

Seniority: Manager level

Key Responsibilities

•Lead a small team of Product Complaints Engineers focused on one or more DEKA medical devices.
•Review and evaluate product complaints related to potential device-related issues with minimal direction.
•Ensure complaint documentation follows Good Documentation Practices, meets QMS requirements, and complies with FDA and other regulatory requirements.
•Identify and make decisions regarding medical device reporting to regulatory agencies; interface with manufacturers, health care professionals, internal customers, and regulatory agencies.
•Support complaint handling through audits and CAPA investigations, align investigations with the forensic investigation team, track process improvements, and author procedures/work instructions while maintaining a product training program.

Key Requirements

•4-year engineering degree (preferably biomedical engineering) with 3+ years of relevant experience in a cGMP environment supporting complaint handling, medical device reporting, or product analysis.
•OR 2-year degree with 5+ years of relevant experience in a cGMP environment supporting complaint handling, medical device reporting, or product analysis.
•Knowledge of FDA Quality Systems requirements and Medical Device Reporting regulations (21 CFR 803, 820, and 211).
•Experience with complaint handling investigations, medical device reporting, or product analysis in a regulated environment.
•Strong written/verbal communication, organizational skills, attention to detail, and sound technical writing.

Education:Bachelor's in Biomedical engineering

Skills:Problem-solvingTime managementCommunicationOrganizational skillsTechnical writing

Tech Stack:CGMPQMSGood Documentation PracticesFDA21 CFR 80321 CFR 82021 CFR 211CAPASalesforce

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 - Team Lead

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 2 hours agoStatus: Live

Job Summary

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: Administration & Executive Assistance

Seniority: Manager level

Key Responsibilities

•Lead a small team of Product Complaints Engineers focused on one or more DEKA medical devices.
•Review and evaluate product complaints related to potential device-related issues with minimal direction.
•Ensure complaint documentation follows Good Documentation Practices, meets QMS requirements, and complies with FDA and other regulatory requirements.
•Identify and make decisions regarding medical device reporting to regulatory agencies; interface with manufacturers, health care professionals, internal customers, and regulatory agencies.
•Support complaint handling through audits and CAPA investigations, align investigations with the forensic investigation team, track process improvements, and author procedures/work instructions while maintaining a product training program.

Key Requirements

•4-year engineering degree (preferably biomedical engineering) with 3+ years of relevant experience in a cGMP environment supporting complaint handling, medical device reporting, or product analysis.
•OR 2-year degree with 5+ years of relevant experience in a cGMP environment supporting complaint handling, medical device reporting, or product analysis.
•Knowledge of FDA Quality Systems requirements and Medical Device Reporting regulations (21 CFR 803, 820, and 211).
•Experience with complaint handling investigations, medical device reporting, or product analysis in a regulated environment.
•Strong written/verbal communication, organizational skills, attention to detail, and sound technical writing.

Education:Bachelor's in Biomedical engineering

Skills:Problem-solvingTime managementCommunicationOrganizational skillsTechnical writing

Tech Stack:CGMPQMSGood Documentation PracticesFDA21 CFR 80321 CFR 82021 CFR 211CAPASalesforce

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