Process Engineering Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7jauwn

Our client, a biomedical company in its pre-commercial phase and supported by well-known investor, is looking for a:
**Process Engineering Manager** The company is pioneering a new generation of breast implants designed to be naturally absorbed and replaced by adipose tissue: it is a natural, one-step solution for breast reconstruction following mastectomy, while also enabling effective tumor tracking during radiotherapy. The company is currently in a scaling and industrialization phase, aiming to bring cutting-edge tissue engineering solutions to the global market. **Role Overview** The Process Engineering Manager leads all technical support operations related to manufacturing process development, end-to-end validation, and pilot operations transfer and scale-up. The role oversees both current product families and the development of new platform technologies. A key mission is to standardize processes and capabilities to enable efficient technical training and support capacity demands, while ensuring full compliance with quality and regulatory requirements. The figure holds both strategic and operational responsibilities: from hands-on implementation and problem solving to participating in strategic company initiatives, defining vision, and contributing to the growth and evolution of the engineering function. This includes hiring, mentoring, and performance reviews. The role reports initially to the CTO and later to the COO. **Main Responsibilities**: - Drive integration of product and process development through collaboration with cross-functional teams (25%)
- Build and grow the Engineering function, team, and capabilities to support a scaling business (15%)
- Lead development of systems, methods, equipment, and technologies to improve process capability and support semi-automation and capacity expansion (20%)
- Implement project management discipline to standardize operator training, certification,



and transition to manufacturing (15%)
- Ensure compliance with QMS systems, and proactively manage GMP documentation, equipment maintenance, and facility compliance (15%)
- Provide cross-functional support in solving complex technical issues, including NCR/CAPA management, supplier quality, and QA collaboration
- Manage departmental budget and capital/expense planning (5%)
- Actively contribute to strategic initiatives, cross-functional alignment, and roadmap execution (5%) **Requirements**: - Bachelor’s degree in Engineering or a relevant technical field (Master’s/PhD preferred)
- 15+ years of experience in technical and leadership roles within manufacturing/biotech
- Proven experience with the operational component of commercial readiness (i.e. manufacturing validation, scale-up, capacity planning, appropriation of planning systems, data configuration & item master management for implementation of ERP systems, some orientation of standard cost structure, etc.)
- Strong command of Six Sigma, Lean, GMP, and Design for Manufacturability. Certified Six Sigma Black Belt preferred
- Significant experience in managing compliance processes, technical documentation, and remediation activities related to FDA or similar authorities (510(k), IDE, PMA)
- Strong team leadership, coaching, and people development skills
- Track record of managing cross-functional projects and fostering a culture of excellence
- Clear, open communication style with the ability to influence and align teams
- Ability to navigate complexity, set direction, negotiate for resources, and support interdepartmental consensus-building
- Entrepreneurial mindset with a hands-on approach to both strategic and operational challenges
- Fluency in English is mandatory **Sede di lavoro**: Milano Contratto di lavoro: Tempo completo Retribuzione: €45.000,00 - €60.000,00 all'anno Disponibilità: - Dal lunedì al venerdì Retribuzione supplementare: - Bonus Lingua: - Inglese (Obbligatorio)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7jauwn