Senior Design Quality Engineer

Capgemini; Andover (MA); On-site; USD 61,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Job summary

Executive Senior Design Quality Engineer position in the Greater Boston area (Andover, MA) for a medical device client. On-site, contract for 5 months with ongoing opportunities.

Primary focus on software design controls, risk management, and SDLC compliance across the full lifecycle from concept through post-market activities. Responsibilities include leading DHF/DMR/DHR traceability, CAPA and RCA efforts, and coordination with cross-functional teams to meet regulatory submissions (IDE, PMA, EU

Qualifications

• Experience in FDA-regulated medical device software environments.
• Experience with software design reviews, architecture reviews and SDLC deliverables.
• Strong risk management knowledge (ISO 14971) and software risk controls.

Responsibilities

• Serve as Senior Design Quality Engineer on product development teams, ensuring software design controls across lifecycle phases.
• Establish and maintain DHF, DMR, DHR with traceability from user needs to verification/validation evidence.
• Lead risk management activities and ensure integration of risk controls into design/validation.

Skills

Software quality

SDLC

Risk management

FMEA

CAPA

Root cause analysis

IEC 62304

QMS for software

C/C++/C#

Regulatory submissions

Education

Bachelor's degree in Software/Computer/Systems Engineering or related

Advanced degree preferred

ASQ CQE/CSQE or Six Sigma certs a plus

Job description

Senior Design Quality Engineer (Contract)

Andover, MA, United States (On-site)

Contract (5 months 1 day)

Published 2 days ago

On hold

C/C++

root cause analysis

capa

Object - Oriented Programming (OOP)

sdlc

As a Senior Design Quality Engineer for our medical device manufacturer client in the Greater Boston region, you will be responsible for ensuring end-to-end design quality and compliance across the product development lifecycle for Class II/III medical devices. Working directly with cross-functional teams, you will drive adherence to design controls, risk management, and SDLC best practices from concept through commercialization and post market activities.

Key Responsibilities

• Serving as the Senior Design Quality Engineer on product development teams, ensuring compliance with design controls(specifically software) across all lifecycle phases (planning, inputs/outputs, verification, validation, transfer, and change management)
• Establishing and maintaining DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence
• Responsible for leading and maintaining risk management activities (hazard analysis, FMEA, risk files) and ensuring integration of risk controls into design and validation activities
• Providing quality oversight of software SDLC activities, ensuring compliance with applicable standards (e.g., IEC 62304) and integration with system-level risk management
• Reviewing and approving design, software, and validation deliverables to ensure completeness, consistency, and audit readiness
• Supporting verification, validation, and design transfer activities, ensuring alignment between design outputs and production processes
• Responsible for leading or supporting CAPA, nonconformance investigations, and root cause analysis to drive continuous improvement
• Supporting internal and external audits (FDA, Notified Body, ISO), and contributing to regulatory submissions (e.g., IDE, PMA, EU MDR)

Required Skills

• Mandatory experience supporting software quality within the SDLC and understanding of software risk management principles
• Experience participating in software design reviews, software architecture reviews, and assessment of software lifecycle deliverables including requirements, architecture/design documentation, traceability, verification, and validation evidence
• 10+ years’ experience in FDA regulated, IEC 62304 medical device software environments, with a focus on Software Design Assurance/Control, detailed knowledge of Risk Management (ISO 14971), SDLC and strong understanding of QMS supporting Software Design Controls
• Strong experience with complex medical systems for connected/embedded technologies
• Proven experience in Root Cause Analysis, Software V&V, identifying/ supporting processes and design quality tools for use in tracking/preventing software defects, design traceability, Design for Quality (DfQ), Agile, and SAFe
• Experience supporting software-related regulatory submissions and audits (e.g., IDE, PMA, 510(k), EU MDR) and defending software quality and design control documentation
• Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams
• Ability to interpret software design and code (C/C++/C# or any other object-oriented language) to verify implementation of requirements

Qualifications

• Bachelor's degree in Software Engineering, Computer Engineering, Systems Engineering, Biomedical Engineering, Electrical Engineering, or a related technical discipline
• Advanced degree (Master’s) in Engineering, Quality, or Regulatory Affairs preferred
• Relevant certifications (e.g., ASQ CQE, CSQE, Six Sigma Green/Black Belt) are a plus

The pay range that the employer in good faith reasonably expects to pay for this position is $43.92/hour - $68.62/hour. Applications will be accepted on an ongoing basis.

• medical
• dental
• vision
• retirement

Tundra Technical Solutions is among North America’s leading providers of Staffing and Consulting Services. Our success and our clients’ success are built on a foundation of service excellence. We are an equal opportunity employer, and we do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, age, veteran status, disability, genetic information, or other applicable legally protected characteristic. Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law, including the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. Unincorporated LA County workers: we reasonably believe that criminal history may have a direct, adverse and negative relationship with the following job duties, potentially resulting in the withdrawal of a conditional offer of employment: client provided property, including hardware (both of which may include data) entrusted to you from theft, loss or damage; return all portable client computer hardware in your possession (including the data contained therein) upon completion of the assignment, and; maintain the confidentiality of client proprietary, confidential, or non-public information. In addition, job duties require access to secure and protected client information technology systems and related data security obligations.