R&D Sustaining Engineer II

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 120,000 - 180,000; Full time

Job summary

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. is seeking an experienced R&D Engineer III to join the Galway Interventional Cardiology and Vascular Therapies Sustaining R&D team.

You will independently execute sustaining engineering projects, collaborating with cross-functional teams to implement design improvements throughout the product lifecycle. The role involves analyzing technical data, supporting design changes with robust validation, and ensuring regulatory compliance while

Qualifications

• HETAC Level 8 / Bachelor Degree in Mechanical, Biomedical, Polymer, Materials or related Engineering discipline.
• At least 4 - 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.

Responsibilities

• 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.

Skills

Sustaining Eng

Cross-functional

Design changes

Risk assessment

Regulatory compliance

Data analysis

Communication

Product lifecycle

Education

Bachelor in Mechanical/Biomedical Eng

Job description

Boston Scientific Medical Device (Malaysia) Sdn. Bhd. 4.2 View all jobs

• Boston Scientific is seeking an experienced R&D Engineer III 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 Responsibilities

• 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 4 - 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.