Role Overview
As a Senior Design Quality Engineer (DQE) 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, including software‑driven and active implantable products. 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 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., IEC62304) 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, EUMDR)
Required Skills
10 years of experience in Quality Engineering supporting regulated medical device development (ClassII/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., 21CFR820, ISO13485, ISO14971, IEC62304)
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 the ability to work effectively across cross‑functional teams
Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes
Mandatory Skills
10 years of experience in software quality assurance within regulated environments (medical device preferred)
Experience supporting IDE, PMA, or similar regulatory pathways with an understanding of clinical evidence requirements
Strong understanding of SDLC and design controls in regulated environments (e.g., traceability, DHF)
Proven experience reviewing and improving SOPs or quality processes for regulatory compliance
Hands‑on experience with software verification and validation using risk‑based approaches aligned with FDA expectations
Familiarity with FDA regulations and standards (e.g., 21CFR820,812,814)
Experience with test management, defect tracking, and quality documentation tools
Strong analytical, documentation, and stakeholder communication skills with the ability to influence quality decisions
Qualifications
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., ASQCQE, CSQE, Six Sigma Green/Black Belt) are a plus
Contract Details
Remote
Contract (7 months)
Compensation & Benefits
The pay range that the employer in good faith reasonably expects to pay for this position is $43.92 per hour – $68.62 per hour. Our benefits include medical, dental, vision, and retirement benefits.
About the Employer
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.
#J-18808-Ljbffr
