обновлено 5 дней назад
Senior Project Manager (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Project Manager (Medical Devices): Leading complex medical device development programs from feasibility and concept through validation, production transfer, and sustaining manufacturing with an accent on cross-functional leadership, budgets, schedules, and regulatory compliance. Focus on design controls, risk analysis, ISO standards, manufacturing processes, and delivering high-complexity programs through product launch.
Location: Alajuela, Costa Rica
Company
develops and manufactures medical device products and related components in collaboration with customers, clinicians, suppliers, and strategic partners.
What you will do
- Lead cross-functional internal teams, external vendors, suppliers, and strategic partners across complex product development programs.
- Drive product development from feasibility and concept through validation, production transfer, product launch, and sustaining manufacturing.
- Manage project scope, schedules, budgets, internal billing, transfer cost of goods sold, risks, constraints, and mitigation plans.
- Maintain structured communication with clinicians, customers, internal teams, and key stakeholders while resolving issues and reporting project status.
- Oversee design and process documentation, test and measurement fixtures, change control, traceability, and audit readiness.
- Mentor engineering staff, allocate tasks, support team development, and contribute to quoting and proposal development for new business opportunities.
Requirements
- Bachelor’s degree in Engineering, Chemistry, Biology, or a related scientific or technical field.
- 8+ years of experience in the medical device or related industry, including 6+ years in project or program management within manufacturing.
- Experience managing schedules, budgets, scope, progress, reporting, prototyping, and product launches within a project plan framework.
- Experience with silicone materials, plastics, extrusions, engineering drawings, injection molding, catheter manufacturing, equipment, and assembly.
- Deep understanding of ISO 13485, ISO 14001, ISO 14971, GMP, FDA requirements including 21 CFR 820, MDR, CE design controls, and other country-specific regulations.
- Advanced experience with design of experiments, statistical problem-solving, Lean/Six Sigma, risk analysis, and high-complexity development programs.
Nice to have
- Advanced degree or MBA.
- Experience training team members and contributing to employee performance evaluations.
- Knowledge of program management best practices across the full product life cycle.
Culture & Benefits
- Full-time employment with an emphasis on diversity and inclusion.
- Collaborative, high-performance environment focused on efficiency, innovation, teamwork, and regulatory excellence.
- Opportunity to mentor engineering staff and influence project and program management practices.
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