Senior design quality assurance engineer

12 months contract

About the Role:
The Neuromodulation Design Quality Assurance Engineer role will serve on a high-performing, cross-functional product development team to design world class Neuromodulation Systems. This role supports Neuromodulation division products and collaborates with many different cross-functional and cross-site teams. You will support Design Activities, Risk Management and Post Market Surveillance processes.

Responsibilities:
Perform quality trending using the complaint and NCEP/CAPA systems. Perform and/or lead risk analyses for CAPA and/or audit findings investigations.
Provides design quality input as a subject matter expert and/or independent reviewer. Support internal and external regulatory audits as required.
Be a strong team member, fully motivated to achieve and demonstrate best practices aligned with the division’s objectives.

Necessary requirements:
Education: Bachelor’s degree in mechanical, industrial, electrical, or biomedical engineering (or other related technical discipline)

Experience: 5+ years’ experience in design quality, system test, systems R&D, or product development engineering in medical devices/regulated industry

Skills:
Communication skills in both English and Spanish
Understanding and demonstrated use of industry standards, within product design and development process.
Strong ability to navigate ambiguous situations in a collaborative, innovative, and people-centric team environment.
Knowledge of key regulatory requirements including ISO 13485 Quality Management Systems, ISO 14971 Risk Management, 21 CFR 820, and EU MDR.

English Level: Advanced (B2+, both written and spoken)

Profesional

Bachillerato universitario

Ingeniería Eléctrica - Electromecánica Electrónica y Mecatrónica

Ingeniería Industrial

Ingeniería Mecánica

Ingenierías Otras

Ingeniería Química

5 años de experiencia

1 Vacante