Lead and manage new product introduction (NPI) projects from concept through commercialization, including project planning, budgeting, resource management, and stakeholder communication.
Drive the design, development, prototyping, and testing of new medical devices, ensuring compliance with customer requirements, design inputs, and applicable regulatory standards.
Oversee design verification and validation, process validation (IQ/OQ/PQ), and test method development, ensuring robust, compliant, and scalable manufacturing processes.
Collaborate cross-functionally with product development, quality, manufacturing, regulatory, customers and suppliers to ensure design for manufacturability (DFM), risk management (PFMEA), and smooth design transfer to production.
Provide technical leadership and mentoring to less experienced engineers, guiding problem-solving, process improvements, and quality initiatives to support continuous improvement.
May supervise a small team of Engineer I or Technician colleagues.
Lead risk management activities, including the development of risk analysis, validation protocols, and quality control plans to ensure product and process compliance.
Utilize statistical tools (DOE, SPC, Minitab) to analyze data, improve process capability, and support quality decision-making; manage nonconformance, CAPA, and change control processes.
Support and participate in supplier qualification, vendor assessments, customer communication, and regulatory audits while ensuring alignment with ISO, applicable regulatory and company standards.
Support new business acquisition through the quotation process.
Define and control production process including tooling and equipment.
Validate design specifications and shop floor application of new product, tools, or equipment.
Working closely with Operations team to ensure all facilities are prepared for new product launches.
Define Capex needs for and scalability plans, including facility planning for new product launches.
Bachelor's/University degree in Engineering (Mechanical, Biomedical etc.), or related science/technical field.
8+ years' experience in medical device or related industry experience.
Experience in supporting regulatory submissions and managing audits related to manufacturing and NPI processes.
Experience in integrating new technologies and innovative solutions into the manufacturing process.
In-depth knowledge of manufacturing equipment and automation systems, and the ability to optimize their utilization.
Understanding of advanced manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing and assembly, including the materials used.
Advanced understanding of ISO standards.
Extensive knowledge of GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements.
Expertise in leading process validation and verification efforts to ensure consistent product quality and compliance with regulatory standards and necessary safety protocols.
Advanced knowledge of quality control tools such as statistical process control (SPC) and root cause analysis.
Strong knowledge of product testing and inspection methods, including developing test protocols and overseeing testing activities to ensure compliance with specifications and standards.
Ability to create and maintain technical documentation, including work instructions, standard operating procedures (SOPs), and production records.
Deep understanding of the NPI process and ability to lead the introduction of new products into the manufacturing environment and advanced problem-solving skills to identify and resolve issues that may arise during manufacturing process.