R&D Technical Leader

Description

• Lead sustaining engineering activities and product lifecycle initiatives for the disposable kits portfolio.
• Manage engineering changes, including impact assessments, risk evaluations, and stakeholder alignment.
• Drive implementation of product, material, supplier, and process changes.
• Support lifecycle management activities such as obsolescence management and component substitutions.
• Coordinate verification activities required to support product modifications.
• Conduct risk assessments and contribute to root cause investigations.
• Resolve technical, quality, and manufacturing issues through cross-functional collaboration.
• Maintain technical documentation in accordance with quality system and design control requirements.
• Partner with Manufacturing, Quality, Regulatory Affairs, Supply Chain, and suppliers to ensure successful project execution.
• Support CAPAs, non-conformance investigations, audits, and quality-related activities.
• Identify risks proactively and drive mitigation plans to ensure project delivery.
• Contribute to continuous improvement initiatives across products and processes.

Profile

• Academic degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Plastics Engineering, or a related technical field.
• 6 years of experience in sustaining engineering, product development, manufacturing engineering, or product lifecycle management.
• Proven experience managing engineering changes and technical documentation within a regulated environment.
• Good understanding of medical device and/or biopharmaceutical industry requirements.
• Knowledge of Design Control principles and ISO 13485 standards.
• Experience with single-use technologies, disposable systems, plastics, or tubing assemblies is highly desirable.
• Familiarity with manufacturing processes such as assembly, injection molding, extrusion, or sterilization technologies.
• Working knowledge of risk management, root cause analysis, and product verification activities.
• Ability to independently lead technical activities and coordinate multiple stakeholders.
• Strong analytical and problem-solving capabilities.
• Excellent communication skills and ability to collaborate across international teams.
• Fluent in English; French is considered a strong asset.

Job Offer

• Exciting temporary opportunity within a leading life sciences organization.
• Exposure to innovative technologies and complex engineering challenges.
• Collaborative international environment with strong cross-functional interaction.