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Job Details

Skills

Product Design
Functional Design
Design Documentation
DMR
Change Control
Research and Development
Regulatory Affairs
Functional Requirements
Continuous Improvement
Regulatory Compliance
Life Sciences
Health Care Administration
Industrial Engineering
Quality Assurance
Design Controls
Product Lifecycle Management
Verification And Validation
Change Request Management
ISO 13485
ISO 9000
FMEA
Risk Management
Corrective And Preventive Action
Auditing
Quality Management
QMS
Communication
Documentation
Analytical Skill
Collaboration
Product Development
Manufacturing
Medical Devices

Product Design
Functional Design
Design Documentation
DMR
Change Control
Research and Development
Regulatory Affairs
Functional Requirements
Continuous Improvement
Regulatory Compliance
Life Sciences
Health Care Administration
Industrial Engineering
Quality Assurance
Design Controls
Product Lifecycle Management
Verification And Validation
Change Request Management
ISO 13485
ISO 9000
FMEA
Risk Management
Corrective And Preventive Action
Auditing
Quality Management
QMS
Communication
Documentation
Analytical Skill
Collaboration
Product Development
Manufacturing
Medical Devices

Summary

Job Description:
The Product Design Quality Engineer is responsible for supporting quality throughout the product development lifecycle by ensuring compliance with regulatory requirements, quality standards, and design control processes. This role partners with cross-functional teams to integrate quality into product development, risk management, validation, and manufacturing transfer activities.
Responsibilities:

Support Design Control activities throughout the product development lifecycle in accordance with FDA and international regulatory requirements.
Participate in design planning, cross-functional design reviews, and verification and validation (V&V) activities to ensure product quality objectives are achieved.
Review and approve design documentation, including design inputs, outputs, specifications, and technical records.
Maintain design traceability documentation, including Design History Files (DHF), Device Master Records (DMR), and related quality documentation.
Review Engineering Change Requests (ECRs), Engineering Change Orders (ECOs), and design modifications to ensure compliance with established change control procedures.
Collaborate with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality teams to support new product development and manufacturing readiness.
Facilitate Design and Process FMEA activities, hazard analyses, and implementation of effective risk control measures.
Support design transfer activities by ensuring manufacturing processes, documentation, and quality requirements are fully established prior to production.
Participate in internal audits, quality system improvements, CAPA investigations, and continuous improvement initiatives.
Contribute to Quality Management System (QMS) enhancements, documentation updates, and regulatory compliance efforts.

Requirements:

Bachelor's degree in Engineering, Life Sciences, Healthcare Management, Industrial Engineering, or a related technical discipline.
5+ years of experience in Design Quality, Design Assurance, or Quality Engineering within an FDA-regulated medical device environment.
Strong knowledge of Design Controls, Design Assurance principles, and product lifecycle management.
Experience with Design Verification & Validation (V&V), design traceability, engineering change management, and manufacturing transfer.
Working knowledge of medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable international regulatory requirements.
Experience supporting risk management activities, including Design FMEA, Process FMEA, hazard analysis, and risk mitigation.
Familiarity with CAPA, internal audits, quality investigations, and Quality Management Systems (QMS).
Excellent communication, documentation, analytical, and cross-functional collaboration skills.

Preferred Qualifications:

Experience supporting new product development (NPD), design transfer, or manufacturing transfer projects.
Knowledge of Design for Reliability (DfR), product traceability, and defect prevention methodologies.
Experience working with global engineering, regulatory, and manufacturing teams.
Background in respiratory care, patient monitoring, diagnostic imaging, or other medical device technologies is a plus.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: d6f3fa939eaa0bf36d9f8eab40543968
Posted 7 hours ago

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Cambridge, Massachusetts

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Role: Design Quality Engineer Work location: USA (Bothell, WA/Cambridge, MA) Mode of hire: Contract & Full Time Minimum required Education: Bachelor's Degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent. Minimum required Experience: Knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation (EU MD

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Product Design Quality Engineer

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