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R&D Test Lab Lead / chef du laboratoire d'essais at Boston Scientific Corporation Malaysia
Montreal, Quebec, Canada -
Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Biomedical Engineering, Electrical Engineering, Medical Device Verification, Regulatory Requirements, Organizational Skills, Leadership Skills, Laboratory Coordination, Communication Skills, Problem-Solving Skills, Testing Concepts, ISO 13485, IEC 60601, FDA Design Control Standards, Risk Management, Electrical Safety Testing, Biocompatibility Testing

Industry

Medical Equipment Manufacturing

Description
Bachelor's or master's degree in biomedical engineering, electrical engineering, or a related technical field. Strong understanding of medical device verification methodologies and regulatory requirements. Strong organizational, leadership, and laboratory coordination skills. Excellent communication and problem-solving abilities. Technical knowledge of testing concepts for electrical and electro-mechanical equipment. Knowledge of ISO 13485, IEC 60601, and FDA design control standards. Familiarity with risk management principles per ISO 14971. Hands-on experience with electrical safety testing and biocompatibility testing. Baccalauréat ou maîtrise en génie biomédical, génie électrique, génie mécanique ou dans un domaine technique connexe. Solide compréhension des méthodologies de vérification des dispositifs médicaux et des exigences réglementaires applicables. Excellentes compétences en organisation, en leadership et en coordination de laboratoire. Excellentes aptitudes en communication, en collaboration et en résolution de problèmes. Connaissance technique des concepts d'essai pour les équipements électriques et électromécaniques. Connaissance des normes ISO 13485, IEC 60601 et des exigences de la FDA en matière de contrôle de la conception. Familiarité avec la gestion des risques selon la norme ISO 14971. Expérience pratique en essais de sécurité électrique et en essais de biocompatibilité.
Responsibilities
Lead the R&D test lab and coordinate laboratory activities. Ensure compliance with medical device verification methodologies and regulatory standards.