Staff Process Development Engineer

A leading global medical device manufacturer is seeking a Staff Process Development Engineer to join their Penang site.

This role offers you the opportunity to play a pivotal part in designing and developing new manufacturing processes for disposable medical devices, ensuring seamless product transfer into production, and driving process improvements that impact multiple product lines. As a core team member and site lead on cross-functional projects, you will be empowered to manage complex initiatives independently while enjoying a supportive environment that values collaboration, knowledge sharing, and professional growth. The organisation is committed to fostering an inclusive workplace with flexible working opportunities, generous pension contributions, and ongoing training to help you advance your skills and career.

• Take ownership of process development for innovative disposable medical devices, contributing directly to the advancement of healthcare technology.
• Enjoy flexible working arrangements, generous pension contributions, and access to continuous training opportunities designed to support your professional development.
• Work within a collaborative and knowledgeable team environment where your expertise is valued and your input helps shape the future of manufacturing excellence.

What you'll do:

As a Staff Process Development Engineer based in Penang, you will be entrusted with the responsibility of advancing manufacturing processes for cutting-edge disposable medical devices. Your day-to-day activities will involve collaborating closely with cross-functional teams to ensure smooth product transfers into production while continuously seeking ways to improve existing processes. You will leverage your expertise in engineering methodologies such as Six Sigma and Lean to create efficient systems that are 'born lean'—capable from the outset. By coordinating with internal stakeholders as well as external suppliers, you will drive innovation in process development while maintaining rigorous documentation standards required by quality systems. Your role will also include mentoring junior colleagues on best practices in process and product development. Success in this position hinges on your ability to communicate effectively across departments, apply technical knowledge creatively to solve challenges, and deliver impactful improvements that benefit multiple product lines.

• Develop and implement new manufacturing processes for disposable medical devices by applying advanced engineering principles and methodologies.
• Perform Design of Experiments (DOE) to define processes and optimise equipment parameters for both new and existing manufacturing operations.
• Create comprehensive documentation supporting new and improved manufacturing processes, ensuring compliance with quality systems requirements.
• Utilise Six Sigma, Lean, and mistake-proofing techniques to design processes that are efficient, capable, and sustainable from inception.
• Write and execute process validations including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ/PPQ), as well as validate inspection methods for verification and control.
• Interface daily with assemblers, production supervisors, leads, engineers, and management to facilitate effective communication across all levels.
• Coordinate with suppliers and external resources to develop and implement robust process/product plans that meet project objectives.
• Collaborate as part of a development team in creating and launching new devices, ensuring excellent communication among all team members.
• Assess process capabilities, innovate solutions, and implement improvements on key projects with divisional impact across the organisation.
• Apply technical knowledge to design, develop, and refine processes, procedures, tooling, or automation that enhance manufacturing efficiency.

What you bring:

The ideal candidate for the Staff Process Development Engineer position brings substantial experience from regulated industries such as medical devices. Your background includes at least eight years of hands-on involvement in process development activities where you have successfully validated equipment and characterised manufacturing processes. You possess a Bachelor’s degree in Mechanical Engineering or Biomedical Engineering—or an equivalent qualification—and have demonstrated proficiency using Six Sigma methodologies including Design of Experiments (DOE) for optimising production parameters. Your ability to guide junior engineers reflects your commitment to knowledge sharing within collaborative teams. Strong communication skills enable you to connect effectively with colleagues at all levels while your familiarity with quality systems ensures thorough documentation practices. Managing complex projects independently showcases your dependability and adaptability within dynamic environments.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering or a related engineering discipline is required for this role.
• At least 8 years of demonstrated experience in process development or improvement activities within the medical device or other regulated industries is essential.
• Proven track record in equipment validation and process characterisation as well as validation experience is necessary.
• Six Sigma Black Belt certification or demonstrated use of Design for Six Sigma tools such as DOE, problem solving techniques, and process improvement strategies is mandatory.
• Ability to develop manufacturing processes from concept through to production implementation is highly valued.
• Experience guiding and mentoring junior engineers on process and product development is expected.
• Excellent communication skills are crucial for facilitating effective collaboration across diverse teams.
• Familiarity with quality systems requirements including documentation such as GOIs, BOMs, Routers, FMEAs is advantageous.
• Competence in managing complex projects independently with minimal supervision is important for success in this role.

What sets this company apart:

This organisation stands out as a global leader in medical device manufacturing due to its unwavering commitment to employee wellbeing and professional growth. Employees benefit from flexible working opportunities that accommodate individual needs while promoting work-life balance. Generous pension contributions provide financial security for the future. The company invests heavily in training programmes designed to keep staff knowledgeable about industry advancements—ensuring everyone has access to resources needed for personal development. The culture emphasises inclusivity; every team member’s voice is heard regardless of background or experience level. Supportive leadership fosters an environment where collaboration thrives—making it possible for employees not only to excel individually but also contribute meaningfully towards communal goals. With state-of-the-art facilities located in Penang, you’ll find yourself surrounded by passionate professionals dedicated to improving healthcare outcomes worldwide.

What's next:

If you are ready to make a meaningful impact on healthcare technology by advancing manufacturing excellence within a supportive team environment, this opportunity awaits you!

Apply today by clicking on the link provided 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