DEKA Research & Development

3 days ago

Senior Software Quality Engineer

✓ 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

Partner with project managers, system engineers, quality systems, and IT to implement critical software tools for life-changing medical devices. Lead requirement capture and translate user needs into technical requirements. Develop system-level test strategies, specifications, and protocols, including hazards and failure-mode analyses. Support development and configuration of custom validated software tools and guide device development teams with regulatory-quality software practices in an FDA-regulated environment.

Location: Manchester

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Partner with project managers, system engineers, quality systems management, and IT to implement critical software tools.
•Lead requirement capture discussions to convert users’ needs into technical requirements.
•Develop system-level test strategy, test specifications, and test protocols.
•Perform hazards analysis and failure modes analysis and support mitigation design.
•Support development/configuration of custom software tools and guide device development teams through delivery of validated software tools.

Key Requirements

•MS/BS in Engineering, Computer Science, or a related discipline with at least 5 years of experience in an FDA-regulated industry.
•Working knowledge of FDA QSRs, ISO 62304, and GAMP5.
•Excellent organization, communication, and technical leadership skills.
•Proficiency with Microsoft Office tools: Word, Excel, PowerPoint, and Visio.
•Experience writing procedures others can easily follow and supporting requirements definition/management for regulatory compliance (a plus).

Experience:5+ yearsFDA-regulated industryMedical devices

Education:Bachelor's in Engineering, Computer Science (or related discipline)

Skills:OrganizationCommunicationTechnical leadership

Tech Stack:FDA QSRsISO 62304GAMP5Microsoft WordMicrosoft ExcelMicrosoft PowerPointVisio

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

Loading job details...

Preparing the role view and application actions.

DEKA Research & Development

3 days ago

Senior Software Quality Engineer

✓ 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: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Partner with project managers, system engineers, quality systems management, and IT to implement critical software tools.
•Lead requirement capture discussions to convert users’ needs into technical requirements.
•Develop system-level test strategy, test specifications, and test protocols.
•Perform hazards analysis and failure modes analysis and support mitigation design.
•Support development/configuration of custom software tools and guide device development teams through delivery of validated software tools.

Key Requirements

•MS/BS in Engineering, Computer Science, or a related discipline with at least 5 years of experience in an FDA-regulated industry.
•Working knowledge of FDA QSRs, ISO 62304, and GAMP5.
•Excellent organization, communication, and technical leadership skills.
•Proficiency with Microsoft Office tools: Word, Excel, PowerPoint, and Visio.
•Experience writing procedures others can easily follow and supporting requirements definition/management for regulatory compliance (a plus).

Experience:5+ yearsFDA-regulated industryMedical devices

Education:Bachelor's in Engineering, Computer Science (or related discipline)

Skills:OrganizationCommunicationTechnical leadership

Tech Stack:FDA QSRsISO 62304GAMP5Microsoft WordMicrosoft ExcelMicrosoft PowerPointVisio

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