Medical Device Design Quality Engineer

Creative Solutions Services, LLC; Cambridge (MA); On-site; USD 130,000 - 170,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Product Design Quality Engineer to ensure regulatory compliance and quality throughout the product development lifecycle. The role collaborates across R&D, Regulatory, Manufacturing, and Supplier Quality to support design controls, risk management, validation, and manufacturing transfer.

We require 5+ years in design quality within FDA-regulated medical devices, strong knowledge of design controls, V&V, and regulatory standards such as FDA 21 CFR

Qualifications

• 5+ years of experience in Design Quality within FDA-regulated medical devices.
• Strong knowledge of Design Controls and product lifecycle management.
• Experience with Design Verification & Validation (V&V), traceability, and change management.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971 and regulatory requirements.
• Experience with CAPA, internal audits, quality investigations and QMS.

Responsibilities

• Support Design Control activities throughout the product development lifecycle in accordance with regulatory requirements.
• Participate in design planning, cross-functional design reviews, and V&V activities to ensure product quality objectives.
• Review and approve design documentation, including inputs, outputs, specifications, and records.
• Maintain design traceability documentation (DHF, DMR) and related quality records.
• Review ECRs and ECOs to ensure changes meet approval and change control procedures.
• Collaborate with R&D, Regulatory Affairs, Manufacturing, and Supplier Quality for new product development and transfer readiness.
• Facilitate Design and Process FMEA, hazard analyses, and risk control implementation.
• Support design transfer activities ensuring manufacturing processes and quality requirements are established.
• Participate in internal audits, quality system improvements, and CAPA investigations.
• Contribute to QMS enhancements and regulatory compliance efforts.

Skills

Design Controls

Design Assurance

Regulatory knowledge

V&V

Risk management

CAPA investigations

QMS familiarity

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related

Job description

Creative Solutions Services, LLC is seeking a Product Design Quality Engineer to ensure regulatory compliance and quality throughout the product development lifecycle. The role collaborates across R&D, Regulatory, Manufacturing, and Supplier Quality to support design controls, risk management, validation, and manufacturing transfer.

We require 5+ years in design quality within FDA-regulated medical devices, strong knowledge of design controls, V&V, and regulatory standards such as FDA 21 CFR