Boston Scientific Senior R&D Engineer Ireland 923292322
Job Purpose:
on our, you’ll be the technical driver behind product quality, reliability, and lifecycle improvements across a portfolio that includes laser fiber devices for kidney and bladder stone treatment (lithotripsy) and prostate tissue removal (HoLEP). You’ll lead crossfunctional work that keeps our devices safe, effective and available—so patients get the care they need, when they need it. *Your way forward is our way forward".
Key Responsibilities:
Lead sustaining projects from problem definition through change execution: root‑cause analysis, design updates, verification/validation, risk files, change notices and design transfer.
Improve reliability, yield, and cost via data‑driven engineering (DOE, capability, SPC) and Value Improvement initiatives; convert insights into documented, audit‑ready changes.
Own technical decisions for assigned materials/sub‑assemblies; collaborate with Operations, Quality, Supplier/External Ops, Regulatory and Clinical to deliver right‑first‑time outcomes.
Plan and run engineering studies using state‑of‑the‑art laser test equipment; define specs, build test methods, analyze results, and present clear recommendations.
Author high‑quality documentation (protocols, reports, risk updates, ECNs/CNs) that meets design controls and inspection expectations.
Quality & compliance
patient safety and product qualityby maintaining compliance with theQuality Policyand all documented processes (e.g., design controls, risk management, test method validation, process validation).
Minimum qualifications
Hons Bachelor’s degree in engineering (Biomedical or Mechanical preferred).
5+ years engineering experience, including 2+ years in medical device product development or sustaining.
Experience with design change assessment/impact analysis for regulated products.
Proven ability to lead crossfunctional teams and influence without formal authority.
Working knowledge of design controls and risk management (e.g., ISO 14971).
Fundamental understanding of ISO 13485 and/or 21 CFR 820 quality systems.
Preferred qualifications:
Biomedical/anatomical understanding of urological systems.
Strong statistics and data analysis; proficiency with DOE/MSA/Capability.
Experience in polymer‑based medical devices (silicone preferred).
Experience with PLM systems (e.g., Windchill) and technical project management.
Comfortable working across global, cross‑cultural teams.
Self‑starter who plans, schedules, and executes to timelines and budget.
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