Boston Scientific R&D Engineer III 

Ireland, Galway 

284171353

Hybrid Roles:

You're Responsibilities include:

• Monitors daily work operations and provides direction and guidance to individual contributors to achieve unit or project goals.
• Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.

• Apply clinical knowledge, as related to product application, to evaluate identified complaints. Investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Participate in development and modification of regulator decision models with changes in product advances/therapies to uphold consistent compliance with government mandated regulations (domestic & international).
• Author/Approve Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Apply codes to events to facilitate product performance records. Review coding and investigations with engineering, laboratory, and other internal staff.
• Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
• Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.

What We’re Looking For:

• Bachelor's degree in: Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering, Nursing, Pharmacy, Medical Doctor or Related Field.
• English Level desired: C1 or above.
• Experience: 6 years of related or applicable experience or an equivalent combination of education and experience.
• Desired knowledge:

Problem Solving

Experience managing people

Quality background

Preferred - Postmarket experience