R&D Technical Leader – Product Care for Disposable Kits
R&D Technical Leader – Product Care for Disposable Kits
Position: Technical Leader
Project Overview: We are seeking an experienced R&D Technical Leader to support product care activities for disposable kits within our client’s Cell and Gene Therapy Disposables R&D team. This global team of 30 professionals works on sustaining and enhancing legacy products in a regulated environment.
Key Responsibilities:
- Lead the design, development, and design transfer of disposable kits for legacy product engineering projects.
- Ensure complete and compliant product solutions meeting customer expectations and technical specifications (URS, SRS).
- Collaborate with project managers to plan sustaining activities and allocate resources while preventing supply chain interruptions.
- Ensure traceability and fulfillment of URS requirements and regulatory compliance of delivered products.
- Drive design coordination and problem-solving during development.
- Oversee and approve design verification & validation (V&V) activities.
- Manage and validate design transfer activities—both internally and with CMOs.
- Work closely with cross-functional teams (Production, Quality, Supply Chain, Sales & Marketing) and external stakeholders (end-users and suppliers).
Required Qualifications & Experience:
- Master’s degree (or equivalent) in engineering or scientific fields (e.g. mechanics, plastics, biomedical engineering).
- 15+ years of experience in the design, development, and manufacturing of plastic disposable products in regulated industries (e.g. medical devices Class II/III).
- Expertise in design documentation (URS, SRS, FMEA, V&V) and regulatory standards (ISO 13485, FDA 21 CFR Part 820) for US and EU markets.
- Hands-on experience with manufacturing technologies such as injection molding, thermoforming, ultrasonic welding, and rapid prototyping, including validation protocols (FAT, SAT, IQ, OQ, PQ, DOE, SPC).
- Strong project management, analytical, and organizational skills; PMI certification is a plus.
- Excellent communication skills; able to work effectively in matrix, multicultural, and cross-functional environments.
- Fluent in English and French (minimum C1 level in both).
- Customer-oriented and results-driven with a strong quality mindset and integrity.
- Knowledge of Six Sigma or DFSS; certification (Green/Black Belt) is a plus.
- A natural mentor and coach, capable of guiding teams and fostering collaboration.
What we offer you:
At Alten, we offer you the security of a permanent contract while also giving you the liberty to work with multiple prestigious clients. With the luxury of having a wide range of offices around the world, we are in a unique position to provide you with the freedom to experience national and international business opportunities. Thus, we function in a highly innovative market, always being up to date with the latest technologies and making you a pioneer in your field.
Therefore, we offer our employees sought-after trainings and workshops ranging from hard to soft skills and providing you with certificates that will further increase your qualifications, enabling you to participate in ground-breaking projects.
Apply now and be a part of our amazing journey. We believe in growing together!
Seniority Level
Associate
Employment Type
Full-time
Job Function
Consulting and Engineering
Industries
Engineering Services and Pharmaceutical Manufacturing
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