Associate Process Development Manager

A leading global medical device manufacturer is excited to welcome an enthusiastic Associate Process Development Manager to their Penang site!

This is your chance to be at the heart of innovation, designing and developing manufacturing processes for disposable medical devices that truly make a difference. You’ll be empowered to take ownership of impactful projects, drive process improvements across multiple product lines, and play a key role in seamless product transfers into production. The organisation champions collaboration, knowledge sharing, and professional growth—offering you flexible working opportunities, generous pension contributions, and continuous training so you can flourish in your career. Join a vibrant team where your ideas are celebrated and your development is supported every step of the way.

• Lead exciting, high-impact projects with a globally recognised medical device manufacturer, directly contributing to the creation of products that transform patient care and outcomes.
• Immerse yourself in a collaborative and inclusive culture where your expertise is valued, and you’re surrounded by knowledgeable colleagues and supportive leadership dedicated to your growth.
• Enjoy flexible working arrangements, generous pension contributions, and ongoing training opportunities designed to nurture your skills and ensure your long-term success within the organisation.

What you'll do:

As an Associate Process Development Manager in Penang, you’ll dive into the full lifecycle of process development for disposable medical devices. Your days will be filled with energetic collaboration alongside cross-functional teams—including assemblers, engineers, supervisors, suppliers, and management—to bring new manufacturing processes to life. You’ll harness advanced methodologies like Six Sigma and Lean principles to optimise operations while maintaining impeccable documentation standards required by quality systems. By connecting with internal teams and external partners alike, you’ll spark innovation in process improvement projects that ripple across multiple product lines. Your ability to assess capabilities through structured experiments (DOE), validate processes thoroughly, and mentor junior colleagues will be essential in achieving operational excellence. Success means delivering robust solutions that support the launch of new devices while upholding the highest standards of quality—and enjoying every moment as you help shape the future of healthcare technology.

• Design and implement innovative manufacturing processes for disposable medical devices, ensuring smooth transitions from development to production environments.
• Conduct Design of Experiments (DOE) to define processes and optimise equipment parameters for both new and existing operations, driving efficiency and quality.
• Prepare comprehensive documentation for new and improved manufacturing processes, always adhering to rigorous quality system requirements.
• Apply Six Sigma, Lean, and mistake-proof methodologies to create lean processes that deliver consistent results across all product lines.
• Write and execute process validations including IQ, OQ, PQ/PPQ as well as validate inspection methods for verification and process controls.
• Engage daily with assemblers, production supervisors, engineers, management, and other stakeholders to foster effective communication across teams.
• Collaborate with suppliers and external resources to develop and implement new process or product plans efficiently.
• Work closely as part of a development team in creating and launching new devices while facilitating excellent communications among all team members.
• Regularly assess process capabilities, introduce creative solutions, and implement improvements on key projects with divisional impact.
• Utilise technical expertise to design, develop, and refine processes, procedures, tooling, or automation systems that boost manufacturing efficiency.

What you bring:

To thrive as an Associate Process Development Manager at this leading medical device manufacturer in Penang, you’ll bring extensive experience in process development gained within regulated environments—ideally medical devices or similar industries. Your academic background in engineering equips you with the insight needed for complex manufacturing challenges. You have deep expertise in equipment validation protocols (IQ/OQ/PQ/PPQ), process characterisation techniques (DOE), and the application of Six Sigma principles for continuous improvement. Your interpersonal skills shine as you build strong connections across multidisciplinary teams while guiding junior colleagues through technical reviews. You’re adept at producing thorough documentation aligned with quality system requirements—ensuring compliance at every stage. Your proven ability to spark creative solutions that enhance efficiency makes you a valuable asset on divisional projects impacting multiple product lines. Above all else, your commitment to nurturing collaborative relationships ensures successful outcomes for both your team members and the broader organisation.

• Bachelor’s degree in Mechanical Engineering or Biomedical Engineering or a related engineering discipline is required for this position.
• At least 8 years of hands-on experience in process development or improvement activities within regulated industries such as medical devices.
• Proven track record in equipment validations as well as process characterisation and validation activities essential for manufacturing excellence.
• Experience applying Six Sigma Black Belt methodologies or demonstrated use of Design for Six Sigma tools including DOE, problem solving techniques, and process improvement strategies.
• Ability to develop manufacturing processes from concept through to production with meticulous attention to detail.
• Guiding and mentoring junior team members on process and product development tasks is highly valued.
• Excellent communication skills enabling effective collaboration across diverse teams including suppliers, engineers, assemblers, supervisors, and management.
• Strong documentation skills ensuring all aspects of process development meet stringent quality system requirements such as GOIs, BOMs, Routers, FMEAs.
• Experience interfacing directly with production staff as well as coordinating external resources for successful project delivery.
• Technical proficiency in innovating solutions for process improvements on projects with divisional impact.

What sets this company apart:

This organisation stands out as a global leader in medical device manufacturing renowned for its commitment to improving patient lives through cutting-edge technology. Employees benefit from a culture rooted in collaboration where knowledge sharing is encouraged at every level. The company invests heavily in professional development—offering ongoing training opportunities tailored to individual growth aspirations—and supports flexible working arrangements that promote work-life balance. Generous pension contributions reflect their dedication to employee wellbeing while inclusive policies ensure everyone feels valued regardless of background or experience. With dependable leadership focused on nurturing talent within supportive teams, this employer provides an environment where you can thrive both personally and professionally while making meaningful contributions to healthcare innovation.

What's next:

Ready to energise your career by shaping the future of medical device manufacturing processes? Don’t miss out—apply now!

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