Descrizione:
Job Details: Technology Transfer Engineer
Full details of the job.
PurposeAs a Technology Transfer Engineer, you will lead operations for new technologies and platforms within the capital equipment division. Your responsibilities will include developing innovative solutions for manufacturing, testing, and validating cutting‑edge electro‑mechanical systems to achieve top‑level status within the industry. In this role within a dynamic international environment, you will collaborate with leading technical partners worldwide to lay the foundations for the BVI capital equipment portfolio. Additionally, you will lead and support lifecycle management projects focused on enhancing manufacturing processes to improve quality, capacity, and cost‑effectiveness. Lead international New Product Introduction (NPI) projects and initiatives, providing technical expertise.
Key Responsibilities
- Provide system engineering support for corporate projects.
- Serve as a core team member for new product development, collaborating with manufacturing, supply chain, sourcing, and other operations groups to develop and execute optimal plans.
- Introduce and validate new manufacturing technologies, including capital and capacity planning.
- Oversee design controls operations documentation, including plans, protocols, reports, test methods, work instructions, PFMEAs, and control plans, contributing to global regulatory submissions.
- Act as the voice of operations within the design cycle, conducting Design for Excellence (DfX) reviews and ensuring alignment with lean manufacturing principles.
- Partner with R&D to ensure manufacturing infrastructure supports product design and overall project and business needs.
- Conduct process studies to identify opportunities for improving the manufacturing process.
Qualifications
- Master’s degree in engineering (mechanical/electrical/biomedical) and 5+ years of relevant experience, or equivalent combination of education, training, and experience working in a highly regulated industry (medical sector preferred).
- Strong engineering problem‑solving skills.
- Understanding of ISO 13485, ISO 14971, FDA CFR part 820.
- Excellent analytical skills, providing effective support in decisions based on factual data and analysis.
- Expertise in process design and development, including experience with prototyping development and acceptance.
- Ability to work internationally, with expected travel time ranging from 25% to 50%.
- Ability to evaluate, triage, and mitigate risks, both for product and project.
- High‑level knowledge and understanding of electrical wiring and connections, PCBA, and management of electronics (ECAD knowledge will be considered a plus).
- High level Knowledge of and understanding of design and manufacturing of custom mechanical parts (MCAD knowledge will be considered a plus).
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