Engineering Manager

Our client is a global leader in the design, manufacture, and supply of medical devices for respiratory care and support.

They are seeking an experienced Engineering Manager to lead their team at their Penang site. This role offers the opportunity to oversee the design, development, and implementation of engineering projects that meet stringent safety, regulatory, quality, and performance standards in the medical device industry. The successful candidate will have the chance to establish and manage a tooling department, coordinate New Product Introduction transfers from other sites, and support ongoing manufacturing and product improvement initiatives.

* Lead a high-performing engineering team in the medical device industry.

* Oversee design, development, and implementation of engineering projects.

* Establish and manage a tooling department.

What you'll do:

As an Engineering Manager, you will be at the forefront of leading a dedicated team in the medical device industry. Your role will encompass overseeing the design, development, and implementation of innovative products that meet rigorous safety, regulatory, quality, and performance standards. You will also be responsible for setting up and managing a tooling department that supports manufacturing operations. Your leadership will be instrumental in driving New Product Introduction transfers from global sites while ensuring smooth integration into local operations. Collaborating with cross-functional teams will be key to your success as you work towards supporting new and existing product development. Your keen eye for detail will be crucial in reviewing and approving engineering drawings, documentation, and technical specifications. Furthermore, your ability to conduct comprehensive risk assessments will play a vital role in developing effective mitigation strategies.

* Lead and manage the engineering team, ensuring adherence to medical device industry standards.

* Oversee engineering activities including design, development, and implementation of products.

* Ensure all engineering outputs comply with applicable standards such as ISO 13485, FDA 21 CFR Part 820.

* Set up and manage the tooling department.

* Lead the New Product Introduction (NPI) transfer process from global sites.

* Collaborate closely with cross-functional teams to support new and existing product development.

* Review and approve engineering drawings, documentation, and technical specifications.

* Conduct engineering risk assessments and develop effective mitigation strategies.

* Develop and manage engineering budgets, resource planning, and timelines.

* Drive continuous improvement initiatives across engineering operations.

What you bring:

As the ideal candidate for the Engineering Manager role, you bring a wealth of experience and a strong educational background in Engineering. With at least 10 years of experience in an engineering role, preferably within the medical device industry, you have a deep understanding of medical device development and manufacturing processes. Your proven track record in managing engineering projects for medical devices from design to commercial release is essential. You are proficient in CAD software and other relevant engineering tools, with direct experience in tooling setup and management. Your experience in moulding injection, extrusion, and assembly processes will be highly valuable. Your strong leadership, communication, and stakeholder management skills will enable you to lead effectively and collaborate across functions.

* Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical or related field).

* At least 10 years of experience in an engineering role within the medical device industry.

* Strong understanding of medical device development processes.

* Proven experience in managing engineering projects for medical devices.

* Experience with risk management processes in the medical device industry.

* Proficiency in CAD software and other relevant engineering tools.

* Direct experience with tooling setup and management.

* Experience in moulding injection, extrusion, and assembly processes.

* Demonstrated ability to lead NPI transfers from other manufacturing locations.

* Strong leadership, communication, and stakeholder management skills.

What sets this company apart:

Our client is a global leader in the medical device industry, renowned for their commitment to innovation, quality, and patient care. They offer a dynamic work environment that fosters collaboration, continuous learning, and professional growth. Their employees enjoy competitive benefits including group insurance coverage (GHS, Life and PA) and performance-based bonuses. They also provide ample opportunities for professional development.

What's next:

Ready to take your career to new heights? Apply now!

Apply today by clicking on the link or email me at tenghong.khoo@robertwalters.com.my to discuss this new opportunity!

Do note that we will only be in touch if your application is shortlisted.

Agensi Pekerjaan Robert Walters Sdn Bhd
Business Registration Number : 729828-T
Licence Number : JTKSM 423C