QUALIFICATIONS :

• Baccalauréat en génie ou équivalent
• Minimum de 5 ans d’expérience en développement de dispositifs médicaux
• Expérience en assurance qualité est un atout
• Connaissances et expérience préalables des normes suivantes :
• ISO 13485 – Expérience en gestion de système qualité
• 21 CFR – Partie 820 – Réglementation des systèmes qualité
• ISO 14971 – Gestion des risques
• IEC 62304 – Gestion des logiciels pour dispositifs médicaux
• Expérience avec IEC 60601-1 et IEC 60601-1-2
• Familiarité avec les dispositifs médicaux pilotés par logiciel
• Bilingue français et anglais(doit interagir avec des fournisseurs et des sous-traitants à l’extérieur du Québec)

SENIOR MECHANICAL ENGINEER, MEDICAL DEVICE

Join our dynamic team at Jubilant Radiopharma as Senior Mechanical Engineer, Medical Device! We are seeking a driven individual who thrives in a fast-paced environment and is passionate about ensuring the highest standards of quality and compliance in our operations.

QUALIFICATIONS:

• Bachelors in engineering or equivalent
• Minimum of 5 years of experience in medical device development
• Experience in quality assurance is an asset.
• Prior knowledge and experience of the following standards:
• ISO 13485 Quality System management experience
• 21 CFR - Parts 820 Quality System Regulation
• ISO 14971 Risk management
• IEC 62304 (software management for medical device
• IEC 60601-1 and 60601-1-2 Experience
• Familiarity with software driven medical device.
• Bilingual French and English (Must interact with suppliers and contractors outside Quebec)

JOIN US:

If you are looking for a challenging yet rewarding opportunity to make a difference in the healthcare industry, we invite you to apply for the Senior Mechanical Engineer, Medical Device position at Jubilant Radiopharma. Join us in our mission to deliver innovative solutions that enhance patient care and improve lives. Apply now and be part of our success story!
Job Overview

ROLE OVERVIEW:

The Senior Mechanical Engineer in Medical Device Product Development is responsible for driving the successful design, development, and commercialization of innovative medical devices, as well as supporting ongoing lifecycle management.
As a key member of the Medical Device Development Team (MDDT), this role contributes to the creation of safe, effective, and high-quality products. The engineer ensures that development processes are executed efficiently and documented thoroughly, maintaining transparency and compliance throughout.
Working collaboratively with a multidisciplinary team of engineers, scientists, and other professionals, the Senior Mechanical Engineer plays a critical role in bringing cutting-edge medical technologies to clinical environments.

KEY RESPONSIBILITIES:

• Develop mechanical components and assemblies for medical devices, ensuring compliance with functional requirements, usability, and regulatory standards.
• Create detailed 3D models and 2D drawings using CAD tools (e.g., SolidWorks, Creo), including tolerance analysis and design for manufacturability.
• Build and evaluate prototypes through bench testing, simulated use, and verification protocols to ensure performance, safety, and reliability.
• Support risk analysis (e.g., FMEA), design input/output documentation, and traceability in accordance with ISO 13485 and FDA 21 CFR Part 820 requirements.
• Work closely with R&D, Quality, Regulatory, Clinical, and Manufacturing teams to ensure seamless integration of mechanical designs into the final product.
• Work collaboratively with Product Marketing and Business Development personnel to define the scope and requirements of potential development projects and product requirements throughout the life cycle of medical device products.
• Select appropriate materials and manufacturing processes (e.g., injection molding, machining, 3D printing) suitable for medical applications and sterilization methods.
• Oversee medical device standards and requirements verification and validation as applicable, including test method development, fixture design, and data analysis.
• Review proposed design changes and manufacturing process changes for medical devices to ensure compliance and performance integrity.
• Provide oversight of the manufacture and supply of medical devices during the development phase, collaborating with suppliers and contract manufacturers to resolve technical issues and support process validation.
• Manage the creation and maintenance of design history files (DHF), related risk management files and other documentation required for regulatory submissions.
• Generate and maintain engineering Corrective and Preventive Actions (CAPAs), Change Controls (CCs), and investigations. Coordinate completion of CAPAs and CCs associated with the introduction of new devices or design changes.
• Support NPI activities by transitioning designs from development to production, including design transfer, process validation, and ramp-up planning in collaboration with manufacturing and quality teams.
• Identify opportunities for product enhancements, cost reduction, and process optimization while maintaining compliance and patient safety. Support team members in the implementation of design control processes and serve as a mentor in the principles of design control and risk management.