Senior Design Quality Engineer - Medical Devices, Hybrid

Blackrock Neurotech LLC; Salt Lake City (UT); Hybride; USD 110 000 - 160 000; Plein temps

Résumé du poste

Blackrock Neurotech LLC in Salt Lake City is seeking a Senior Design Quality Engineer to guide medical device development from concept to commercialization. You will apply ISO 14971, ISO 13485, and risk management practices across electrical, mechanical, and software domains in a cross-functional team.

You will own design controls, verification and validation plans, and supplier qualification in a hybrid office setting, balancing rigorous quality with rapid innovation in a high-consequence

Qualifications

• Bachelor's degree in engineering or related technical discipline; 8+ years of relevant experience, or master's with 5+ years
• Experience supporting medical device development from concept through commercialization
• Experience with ISO 14971 risk management and FMEA
• Familiarity with ISO 13485 and design controls

Responsabilités

• Provide hands-on Design Quality Engineering support throughout the product development lifecycle, from early design through commercialization
• Partner with electrical, mechanical, software, and systems engineering teams on design controls, requirements, risk management, verification and validation, and design transfer
• Lead product risk management activities, including Risk Management Plans and Reports, hazard analyses and FMEAs in accordance with ISO 14971
• Develop and maintain design control documentation, including requirements, traceability matrices, validation plans, test methods, protocols, and reports
• Apply statistical methods, root cause analysis, and sound engineering judgment to identify and resolve product and design quality issues
• Support broader Quality activities associated with product development, including supplier qualification, ECOs, nonconformances, CAPAs, audits, and continuous improvement

Connaissances

Design Quality Engineering

Medical device development

Risk management

FMEA

Statistical analysis

Formation

Bachelor's degree in engineering or related technical discipline

Master's degree in engineering (optional)

Outils

ISO 14971

ISO 13485

Design controls

Description du poste

Blackrock Neurotech LLC in Salt Lake City is seeking a Senior Design Quality Engineer to guide medical device development from concept to commercialization. You will apply ISO 14971, ISO 13485, and risk management practices across electrical, mechanical, and software domains in a cross-functional team.

You will own design controls, verification and validation plans, and supplier qualification in a hybrid office setting, balancing rigorous quality with rapid innovation in a high-consequence