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INSPYR Solutions · 2 months ago

Quality/Design Controls Engineer - Remote

United States

Full-time

Remote

Mid, Senior Level

$50/hr - $60/hr

INSPYR Solutions is a national expert in delivering flexible technology and talent solutions. The Design Controls Engineer will ensure compliance with design controls, risk management, verification/validation, and design transfer in accordance with industry standards.

Information TechnologyProfessional ServicesStaffing Agency

No H1B

U.S. Citizen Only

Responsibilities

Establish and own Our company's Design & Development procedures (ISO 13485 §7.3), including templates for Design Plans, Design Inputs/Outputs, Reviews, and Design History Files (DHFs) for Hardware and Software

Lead cross-functional design reviews across hardware, software, and material development teams; ensure risk, validation, and change control are integrated

Develop and maintain DHFs, DMRs, and MDFs for scanner systems, inks, and associated digital design software

Drive risk management activities per ISO 14971, integrating hazard analysis, FMEAs, and risk traceability

Author and review verification and validation protocols/reports, including equipment qualifications (IQ/OQ/PQ), material validation, and software lifecycle documentation (per IEC 62304)

Establish Design Transfer protocols, linking development to manufacturing and ensuring traceability through BOMs, DHRs, and process validation

Coach internal teams on design control expectations for both SaMD (software as a medical device) and hardware components

Support audits and submissions, providing SME input on design controls, risk management, and technical files

Implement document and record management structure for all design records in the QMS (Dot Compliance)

Qualification

ISO 13485FDA 21 CFR 820MDSAPISO 14971IEC 62304Design History FilesRisk ManagementSix Sigma Black BeltASQ CQE/CQACommunication SkillsOrganizational Skills

Required

Experience in medical device, dental device, or life sciences industries with a focus on design controls, new product development, and process validation

Proven track record of building design control frameworks from the ground up (startups or greenfield environments preferred)

Deep knowledge of ISO 13485, FDA 21 CFR 820, MDSAP, ISO 14971, and IEC 62304 (software lifecycle)

Strong experience with hardware and material design verification (scanner systems, inks, or similar digital manufacturing devices)

Experience leading design and risk reviews, authoring Design History Files (DHF), Risk Management Files (RMF), and validation documentation

Experience with SaMD classification, validation, and regulatory documentation is a must

Excellent organizational and communication skills; able to bridge quality, engineering, and product teams effectively