4 дня назад
Device Industrial Development Senior Specialist (Medical Devices)
52 240 - 65 300€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Device Industrial Development Senior Specialist (Medical Devices): Leading industrialization, scale-up, validation, and lifecycle management for device constituent parts across manufacturing sites and external partners with an accent on technical governance, regulatory compliance, and business continuity. Focus on coordinating technology transfers, managing changes and risks, solving root-cause investigations, and improving device robustness under medical device quality requirements.
Location: Based in Parma, Italy, with remote working possible only with regular presence in Parma; regular travel to manufacturing sites and external partners is required.
Salary: €52,240–€65,300, plus eligibility for an annual bonus.
Company
is an international research-focused biopharmaceutical group operating in more than 30 countries, developing and manufacturing innovative medicines and managing global technical operations and supply.
What you will do
- Lead industrialization and scale-up projects for Device Constituent Parts, including development, validation, and technology transfer.
- Provide technical leadership for validation, change management, risk assessment, and industrial development across device platforms.
- Coordinate cross-functional projects involving R&D, Quality, Regulatory Affairs, Engineering, manufacturing sites, and CMOs.
- Prepare, execute, and review validation plans, technical protocols, reports, and development studies.
- Support investigations, root cause analyses, corrective actions, and changes affecting Device Constituent Parts.
- Monitor project risks, timelines, and deliverables while driving continuous improvement, manufacturing reliability, and supply continuity.
Requirements
- 8–10 years of experience in medical device and/or drug-device combination product industrialization, validation, and lifecycle management.
- Strong engineering background with hands-on product development, industrialization, and manufacturing experience.
- Experience leading cross-functional technical projects across Quality, Engineering, manufacturing sites, and external partners.
- Knowledge of regulated environments, validation, change management, risk assessment, Medical Device Regulation, ISO 13485, ISO 14971, and cGMP.
- Strong analytical, problem-solving, stakeholder management, and communication skills.
- Fluent written and spoken English; regular presence in Parma and travel to manufacturing sites and external partners are required.
Culture & Benefits
- Flexible working arrangements with remote work options subject to regular presence in Parma.
- Company pension and private medical insurance.
- Wellbeing and flexible benefits programmes.
- Annual performance bonus scheme.
- Training, development resources, work-life balance initiatives, and tax assistance services for foreign colleagues.
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