Advanced Manufacturing Engineer - MedTech

Knowles Electronics (Philippines) Corporation is seeking an experienced Advanced Manufacturing Engineer to support and lead manufacturing engineering initiatives for new Medical Technology (MedTech) programs. This role is responsible for developing robust manufacturing processes, ensuring process capability, supporting validation activities, and facilitating successful product transfers from development into mass production.

The ideal candidate brings a strong manufacturing engineering background, hands-on experience with process development and improvement, and the ability to work effectively in a highly regulated environment where quality, reliability, and operational excellence are critical.

Key Responsibilities

Lead the introduction of new and redesigned MedTech products, ensuring manufacturing readiness and smooth integration into production.

Plan, execute, and support process development, characterization, qualification, and validation activities using established manufacturing and quality principles.

Create and maintain essential manufacturing documentation, including process flow diagrams, PFMEAs, control plans, work instructions, and related technical records.

Analyze manufacturing processes to improve yield, reduce defects, and address process challenges through structured root cause analysis and corrective actions.

Partner closely with R&D, Quality, Operations, and Supply Chain teams to ensure successful transfer of products and processes from development to production.

Apply Lean Manufacturing, Six Sigma methodologies, Design of Experiments (DOE), Statistical Process Control (SPC), and other analytical tools to improve process capability, productivity, quality, and cost performance.

Support the selection, qualification, and implementation of manufacturing equipment, tooling, fixtures, and automation solutions, including engagement with suppliers and vendors.

Work with subcontractors and external manufacturing partners to develop and deploy robust production processes for MedTech applications.

Assess emerging manufacturing technologies and identify opportunities that support innovation and business growth.

Drive productivity and value-creation initiatives that enhance operational efficiency and support organizational objectives.

Participate in international travel as required for product transfers, supplier collaboration, and technical alignment activities.

Qualifications

Education

Bachelor's degree in: Electrical Engineering, Electronics and Communications Engineering, Mechanical Engineering, Materials Science, Industrial Engineering, Physics or a related engineering/science discipline

Experience

• At least 3–5 years of experience in Manufacturing Engineering, Process Engineering, Product Engineering, or Advanced Manufacturing Engineering roles.
• Experience working in high-volume manufacturing environments.
• Experience supporting New Product Introduction (NPI), product transfers, or scaling products from development to production.
• Strong preference for candidates with experience in:

Medical device manufacturing

Medical equipment or medical component manufacturing

Pharmaceutical manufacturing

Aerospace manufacturing

Other highly regulated industries

• Exposure to process validation methodologies, structured manufacturing documentation, and compliance-driven production environments is highly desirable.

Technical Skills & Competencies

• Strong knowledge of advanced manufacturing processes and assembly techniques.
• Understanding of process qualification and validation requirements within regulated industries.
• Proficiency in:

Statistical Process Control (SPC)

Design of Experiments (DOE)

Statistical analysis tools

Root cause analysis methodologies

• Experience developing equipment specifications, tooling, fixtures, and manufacturing solutions.
• Knowledge of Lean Manufacturing and Six Sigma principles.
• Working knowledge of ISO 9001; familiarity with medical device quality systems is an advantage.
• Proficiency in Microsoft Excel and other documentation, manufacturing, and analysis software tools.
• Strong communication, collaboration, and stakeholder management skills.
• Experience training and mentoring engineers, technicians, and production personnel.
• Detail-oriented, self-driven, and able to thrive in fast-paced product development environments.