Senior Manufacturing Engineer at Boston Scientific Corporation Malaysia

Cluain Meala, Munster, Ireland -

Full Time

Start Date

Immediate

Expiry Date

08 Mar, 26

Salary

0.0

Posted On

08 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Manufacturing Engineering, Equipment Validation, Process Improvement, Lean Methodologies, Six Sigma, Automation, Digitalisation, Technical Documentation, GMP Compliance, FDA Regulations, Mentorship, Problem-Solving, Analytical Skills, Collaboration, Risk Management, Process Optimisation

Industry

Medical Equipment Manufacturing

Description

Lead engineering initiatives with a strong focus on the full equipment and systems validation lifecycle (IQ/OQ/PQ) across packaging, sterilisation, and shipping processes, ensuring alignment with internal procedures and regulatory standards. Evaluate, select, and implement new equipment, technologies, and processes through rigorous research, analysis, and application of engineering best practices. Manage backend operations — including packaging, sterilisation, and shipping — to meet production targets and maintain seamless supply chain performance. Drive automation and digitalisation projects to enhance operational efficiency, reliability, and compliance. Support product and process validation activities, including documentation development and execution of qualification protocols. Collaborate on new product introductions and technology transfers, ensuring smooth integration into existing manufacturing systems. Identify and lead process improvement initiatives using Lean, Six Sigma, or equivalent methodologies to reduce waste and optimise performance. Review and contribute to technical documentation, change controls, reports, and memos to support continuous improvement and knowledge transfer. Provide hands-on technical leadership and mentorship to junior engineers and technicians, fostering a culture of learning and accountability; act as a people leader when required to coach, develop, and performance-manage direct reports or project teams. Ensure full compliance with GMP, FDA, BSI, EEO regulations and internal quality systems, supporting audits and inspections as required. Actively participate in cross-functional teams, working closely with Quality, Regulatory Affairs, Operations, and Supply Chain to deliver business-critical outcomes. Honours bachelor's degree in Mechanical, Manufacturing, or Biomedical Engineering . Minimum 5 years' experience in a regulated manufacturing environment (MedTech or pharma). Proven experience in at least two or more of the following: Packaging; Sterilisation; Shipping; Automation; Validation; Process Improvement; Product Launches. People leadership experience desirable — demonstrated ability to mentor, coach, and support engineers and technicians, lead small teams or project groups, and influence cross-functional stakeholders. Strong understanding of GMP, validation protocols, and risk management. Hands-on experience with equipment troubleshooting, process optimisation, and documentation. Familiarity with technical writing, including protocols, reports, and SOPs. Excellent problem-solving and analytical skills. Strong communication and interpersonal abilities. Collaborative mindset with a commitment to mentoring and team development. People leadership capability — ability to support, develop, and motivate engineers and technicians; experience giving constructive feedback and driving team performance. Detail-oriented with a proactive approach to continuous improvement. Ability to manage multiple priorities in a fast-paced, regulated environment.

Responsibilities

Lead engineering initiatives focusing on equipment and systems validation across packaging, sterilisation, and shipping processes. Drive automation projects and support product and process validation activities while collaborating with cross-functional teams.