R&D Technical Leader
Teilzeit
Michael Page
Lead impactful product lifecycle projects. Work with diverse international teams. About Our Client: Our client is a global leader in the life sciences sector, providing innovative solutions that support the development and manufacture of critical therapies. With a strong culture of innovation and quality, the company operates in a highly regulated environment serving customers worldwide. Job 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. The Successful Applicant:
- 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. What's on 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.
Die Stellenanzeige wurde vor Vor 3 Tagen veröffentlicht
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