MSD
MSD

MSD — қатерлі ісік, жұқпалы аурулар, жүрек-қантамыр және метаболизм аурулары, сондай-ақ алдын алуға бағытталған медициналық көмек сияқты негізгі денсаулық мәселелеріне арналған дәрілер мен вакциналарды әзірлейтін жаһандық биофармацевтикалық компания. Америка Құрама Штаттарында, Канадада және Пуэрто-Рикода Merck & Co., Inc. атауымен танымал MSD ғылыми зерттеулерді әзірлеу және коммерцияландыру салаларындағы тәжірибемен ұштастырып, адамдар мен жануарларға арналған денсаулық сақтау шешімдерін ұсынады.

Компанияның қызметі Адам денсаулығы, Жануарлар денсаулығы және Ғылыми зерттеулер мен әзірлемелер бағыттарын қамтиды. Бұл ғылыми, клиникалық, коммерциялық, операциялық және корпоративтік командаларда жұмыс істейтін мамандарға мүмкіндіктер береді. Әлемнің әртүрлі өңірлерінде қызмет атқаратын MSD-дегі мансап мүмкіндіктері зерттеуге, ынтымақтастыққа, инклюзияға және жаһандық денсаулық саласындағы жауапты ілгерілеуге деген ұстанымды көрсетеді.

Senior Scientist, Device Design Controls

Lead device design control activities for pharmaceutical combination products at MSD, supporting development, regulatory compliance, manufacturing readiness, and lifecycle management.

Сипаттама

  • Lead device design control activities for assigned development projects
  • Prepare program presentation materials for management reviews and regulatory submissions
  • Drive implementation and effective execution of device development strategies and design controls
  • Follow approved strategic plans and corporate policies
  • Communicate effectively with cross-functional stakeholders and external suppliers
  • Identify and resolve project obstacles proactively
  • Communicate device development strategies and design control approaches across Device Development and with external suppliers
  • Apply regulatory and compliance requirements for design controls and risk management
  • Help develop, implement, and continuously improve device design control processes, procedures, and tools
  • Support the strategic development of the Device Design Control function and contribute to team goals and initiatives
  • Partner with subject-matter experts across combination product development teams throughout the lifecycle from concept through launch and post-market surveillance
  • Oversee device design control activities that support product quality and efficient manufacturing

Талаптар

  • Bachelor’s or master’s degree in Engineering, Science, or a related discipline with at least six years of related experience
  • At least six years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related field
  • Strong understanding of regulatory requirements and industry standards for device systems
  • Strong analytical and statistical capabilities, including data interpretation and risk assessment tools
  • Excellent communication, leadership, and problem-solving abilities
  • Ability to manage multiple priorities effectively in a dynamic, fast-paced environment
  • Experience developing analytical methods
  • Experience collaborating with external partners
  • Knowledge of Geometric Dimensioning and Tolerancing (GD&T)
  • Knowledge of ISO 13485 for medical devices
  • Knowledge of manufacturing processes
  • Experience with mechanical design
  • Experience with mechanical testing
  • Experience with method validation
  • Experience in product development
  • Experience with prototyping
  • Experience performing statistical analysis
  • Experience with technical writing
  • Applicants must reside in the United States or Puerto Rico
  • Visa sponsorship is not available

Артықшылықтар

  • Annual bonus
  • Long-term incentive when applicable
  • Medical, dental, and vision coverage
  • Additional insurance coverage for employees and families
  • Retirement benefits, including a 401(k) plan
  • Paid holidays
  • Vacation leave
  • Compassionate leave
  • Sick leave
  • Domestic relocation assistance
  • Hybrid work arrangement

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