R&D Sustaining Engineer II

Boston Scientific; Penang; On-site; MYR 307,000 - 425,000; Full time

Job summary

Boston Scientific is seeking an experienced R&D Engineer II to join the Galway ICVT Sustaining R&D team. You will independently execute sustaining engineering projects and collaborate with cross-functional teams to implement design improvements across legacy and next-generation technologies.

The role focuses on lifecycle management of minimally invasive devices for interventional cardiology and vascular therapies, balancing product performance, regulatory compliance and manufacturing

Qualifications

• Sustaining engineering experience in medical devices or regulated environments.
• Experience with design changes and lifecycle management.
• Knowledge of design controls, risk management, and validation processes.
• Strong analytical and stakeholder management skills.

Responsibilities

• Execute sustaining engineering and design change activities with robust justification and risk assessment.
• Plan, prioritize and deliver technical workstreams to meet project timelines.
• Collaborate with Manufacturing, Quality, Regulatory, Clinical, Marketing and PM teams.
• Lead problem-solving activities and implement corrective actions for safety and performance.
• Identify risks early and develop mitigation strategies affecting cost, schedule and manufacturing.
• Partner with Manufacturing and supplier teams to implement design improvements and validations.
• Analyze and communicate technical data to support technical and business decisions.
• Act as a technical expert for commercial products and assist physicians where appropriate.
• Drive continuous improvement in processes and project execution.

Skills

Sustaining engineering

Design changes

Cross-functional collaboration

Technical analysis

Regulatory compliance

Manufacturing support

Risk assessment

Education

HETAC Level 8 / Bachelor Degree in Mechanical, Biomedical, Polymer, Materials or related Engineering

Job description

• Boston Scientific is seeking an experienced R&D Engineer II to join the Galway Interventional Cardiology and Vascular Therapies (ICVT) Sustaining R&D team.
• The ICVT Sustaining R&D group provides design leadership and technical support for a broad portfolio of commercial coronary and vascular intervention products, ensuring safety, regulatory compliance, manufacturing continuity and continuous product improvement throughout the product lifecycle.
• The successful candidate will independently execute sustaining engineering projects while partnering with cross-functional teams to identify and implement design improvements while supporting both legacy and next-generation technologies.
• Responsible for supporting the commercialization and lifecycle management of minimally invasive medical devices for the treatment of IC and VT disease.
• Working with moderate guidance, the successful candidate will independently execute sustaining engineering and design change activities, applying sound engineering judgement to solve technical challenges while balancing product performance, regulatory compliance and manufacturing requirements.
• The role requires compiling, analysing and interpreting technical, operational and research data to make sound engineering recommendations and ensure product design intent is maintained throughout the product lifecycle.
• Acts as a technical expert within project teams, providing product and clinical expertise while influencing technical decisions across cross-functional stakeholders.
• Identifies technical risks and opportunities early, proactively developing mitigation strategies that support project objectives, timelines and business priorities
  

Purpose Statement

• Boston Scientific is seeking an experienced R&D Engineer II to join the Galway Interventional Cardiology and Vascular Therapies (ICVT) Sustaining R&D team.
• The ICVT Sustaining R&D group provides design leadership and technical support for a broad portfolio of commercial coronary and vascular intervention products, ensuring safety, regulatory compliance, manufacturing continuity and continuous product improvement throughout the product lifecycle.
• The successful candidate will independently execute sustaining engineering projects while partnering with cross-functional teams to identify and implement design improvements while supporting both legacy and next-generation technologies.
• Responsible for supporting the commercialization and lifecycle management of minimally invasive medical devices for the treatment of IC and VT disease.
• Working with moderate guidance, the successful candidate will independently execute sustaining engineering and design change activities, applying sound engineering judgement to solve technical challenges while balancing product performance, regulatory compliance and manufacturing requirements.
• The role requires compiling, analysing and interpreting technical, operational and research data to make sound engineering recommendations and ensure product design intent is maintained throughout the product lifecycle.
• Acts as a technical expert within project teams, providing product and clinical expertise while influencing technical decisions across cross-functional stakeholders.
• Identifies technical risks and opportunities early, proactively developing mitigation strategies that support project objectives, timelines and business priorities
  

Job Requirements

• Execute sustaining engineering and design change activities, ensuring proposed product changes are supported by robust technical justification, risk assessment, verification and validation, and that design intent is maintained throughout the product lifecycle.
• Plan, prioritize and deliver technical workstreams, applying advanced engineering judgement to solve complex, multifaceted design, material and process challenges while meeting project timelines.
• Collaborate with cross-functional teams including Manufacturing, Quality, Regulatory, Clinical, Marketing and Project Management to ensure successful project execution and product readiness.
• Support structured problem-solving activities and quality investigations, identifying root causes and implementing effective corrective actions to maintain product safety, quality and performance.
• Identify technical risks and opportunities early, proactively developing mitigation strategies and driving decisions that positively impact product performance, cost, schedule and manufacturing continuity.
• Partner with Manufacturing and supplier teams to apply process development knowledge in implementing design improvements, supporting process optimisation and validation, and delivering continuous product, manufacturing and cost improvements across legacy and next-generation product portfolios.
• Analyse, interpret and communicate technical, operational and research data, preparing clear engineering documentation and recommendations to support technical and business decisions.
• Act as a technical expert for commercial products, applying product, clinical and anatomical knowledge to evaluate field feedback, support physicians where appropriate, and identify opportunities for product enhancement.
• Drive continuous improvement by identifying and leading initiatives that enhance engineering processes, project execution and organisational effectiveness beyond individual projects.
• Provide informal guidance to other engineers, influencing technical decisions and promoting best engineering practices within multidisciplinary and global project teams.
  

Job Qualifications

• HETAC Level 8 / Bachelor Degree (or higher) in Mechanical, Biomedical, Polymer, Materials or a related Engineering discipline.
• At least
• 3 - 6 years relevant R&D engineering experience within the medical device industry or another highly regulated environment.
• Demonstrated experience in product development (NPD) and/or process development, with the ability to apply this knowledge to sustaining engineering and lifecycle management activities.
• Proven experience supporting technical workstreams, design changes or complex engineering projects in a cross-functional environment.
• Working knowledge of design controls, risk management, verification and validation, and change management within a regulated environment.
• Excellent analytical, problem-solving, communication and stakeholder management skills.
  

About Us

As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.