Manage R&D resources to support high impact Research & Development initiatives, including EU MDR, sustaining, and product development.
Key ResponsibilitiesProvides technical leadership within new product development and sustaining engineering portfolios, and design remediation activities to support BVI's EU MDR program.Provides independent technical review and Subject Matter Expert (SME) during Notified Body/ Competent authorities audits.Lead R&D Staff, including goal setting, overall team performance & career development.Collaborate with cross functional management on new initiatives.Embrace continuous NPD process improvement.Identify and drive best practices within the R&D group.Contributes to company Intellectual Property Portfolio.Effectively communicates activity status, issues and mitigation plans with key stakeholders.Provides medical and clinical expert opinions regarding products and procedures for risk management documentation and has responsibility for determining acceptable product safety.Other duties as required.QualificationMINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelor's degree in Mechanical or Biomedical Engineering, or related field; Advanced Degree or MBA preferred.10 years' relevant experience in the medical device industry; or equivalent combination of education, training and experience, with related project management experience and/or team leadership roles.1-3+ years Resource Manager experience, with demonstrated leadership capability to effectively coach, mentor and manage the R&D Team.Experience working on cross functional project teams in the end-to-end lifecycle bringing new products/technologies from concept through commercialization.Knowledge of applicable materials, manufacturing methods and engineering industry standards and specifications.Experience operating in regulated design controls environment.Experience operating in regulated design controls environment with knowledge of ISO, regulatory and legislative standards applicable to the development of medical devices (e.g., FDA, MDR, 13485 etc.).Must work onsite in Rome, Italy.OTHER REQUIREMENTSExcellent knowledge of spoken and written Italian and English.May require travel up to 10%.CompanyBVI is refocusing the future of vision.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products) and PhysIOL (Premium IOLs), and spans more than 90 countries.
We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at www.bvimedical.com
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