Design Quality Engineer Andover, MA

Hiring: Design Quality Engineer Andover, MA

We're looking for an experienced Design Quality Engineer to join a leading Medical Device client on a Long-Term Contract.

Role: Design Quality Engineer

Type: Long Term Contract

Location: Andover, MA

Responsibilities:

Bachelor s degree in Engineering (Biomedical, Software, Systems) 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

Key Responsibilities

Serving as the quality lead on product development teams, ensuring compliance with design controls 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

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

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

10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred)

Strong hands on experience with design controls, DHF management, and traceability in regulated environments

Working knowledge of applicable standards and regulations (e.g., 21 CFR 820, ISO 13485, ISO 14971, IEC 62304)

Experience supporting software quality within the SDLC and understanding of software risk management principles

Proven experience with risk management tools (e.g., FMEA, hazard analysis) and integration into product development

Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation

Strong analytical, documentation, and communication skills with ability to work effectively across cross-functional teams

Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes

Interested or open to new opportunities?
Please send your updated resume with contact details to

Thanks and Regards

Vikas Mahindrakar

Direct:
New York Technology Partners
120 Wood Avenue S | Suite 504 | Iselin, NJ 08830