DEKA Research & Development

3 weeks ago

Junior 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 evaluate product complaints related to potential medical device issues, ensuring documentation follows Good Documentation Practices, QMS requirements, and applicable FDA regulations. Make informed decisions on medical device reporting to regulatory agencies and coordinate with third-party manufacturers, healthcare professionals, and internal stakeholders. Support audits and CAPA investigations, align complaint-related work with forensic investigations, and generate reports and training aids to drive process improvements.

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: Communications, PR & Community

Seniority: Entry level

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 and other regulatory requirements.
•Identify and make sound decisions regarding medical device reporting to regulatory agencies.
•Interface with third-party manufacturers, healthcare professionals, internal customers, and regulatory agencies; participate in audits and CAPA investigations.
•Work with the forensic investigation team on complaint-related investigations, generate process improvement reports, and develop product training aids.

Key Requirements

•4-year biomedical engineering degree, or a 2-year biomedical engineering degree plus 2+ years of relevant experience in a cGMP environment supporting complaint handling, medical device reporting, or product analysis.
•Experience in complaint handling or quality engineering is preferred (school projects and internships considered).
•Knowledge of FDA Quality System requirements and Medical Device Reporting regulations (21 CFR 803, 820, and 211) is preferred.
•Strong motivation to complete tasks through to completion while supporting team goals.
•Exceptional time management, problem-solving, computer proficiency, and strong written/verbal communication with attention to detail.

Experience:2+ yearsMedical devicesCGMP

Education:Bachelor's in Biomedical Engineering

Skills:CommunicationOrganizational skillsProblem-solvingTime managementAttention to detail

Tech Stack:SalesForce

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 weeks ago

Junior 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

Seniority: Entry level

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 and other regulatory requirements.
•Identify and make sound decisions regarding medical device reporting to regulatory agencies.
•Interface with third-party manufacturers, healthcare professionals, internal customers, and regulatory agencies; participate in audits and CAPA investigations.
•Work with the forensic investigation team on complaint-related investigations, generate process improvement reports, and develop product training aids.

Key Requirements

•4-year biomedical engineering degree, or a 2-year biomedical engineering degree plus 2+ years of relevant experience in a cGMP environment supporting complaint handling, medical device reporting, or product analysis.
•Experience in complaint handling or quality engineering is preferred (school projects and internships considered).
•Knowledge of FDA Quality System requirements and Medical Device Reporting regulations (21 CFR 803, 820, and 211) is preferred.
•Strong motivation to complete tasks through to completion while supporting team goals.
•Exceptional time management, problem-solving, computer proficiency, and strong written/verbal communication with attention to detail.

Experience:2+ yearsMedical devicesCGMP

Education:Bachelor's in Biomedical Engineering

Skills:CommunicationOrganizational skillsProblem-solvingTime managementAttention to detail

Tech Stack:SalesForce

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