Responsibilities

Facilitates resolution of complex technical and operational problems.

• Manage and maintain Manufacturer, Repair & Wholesaler license of medical devices comply with standards & requirement by authority.

• Inventory management of capital units, spare part & consumable via managing SAP & OneASP (Based on Salesforce) system.

• Promotes innovation initiatives for new products and ideas.

• Reviews and approves technical documentation to verify compliance to technical specifications and standards.

• Communicates with internal stakeholders and external partners to coordinate and execute project plans.

• Assigns tasks according to projected scopes including compliance and quality improvement, cost reduction, cycle time reduction, capacity increase, raw material qualification, and launch preparation.

• Ensures implementation of multiple new product development plans and programs for the business unit.

• Monitors smooth execution of manufacturing and projects plans and programs at lower levels and cross functionally.

• Allocates proper level of resources to facilitate attainment of project goals within established timelines and budgets.

• Coordinate inventory transfer across locations in ASP stock points.

• Take responsibility of regular stock taking and its reporting for assembling point.

• Leading BOM/Kitting operation for capital unit.

• Manage medical device demo & loaner operations.

• Ensures departmental and company compliance with all local government and company regulations, policies and procedures for health, safety and environmental compliance

Education:

Bachelor's Degree;

Must have: University / bachelor's degree of Mechanical Engineering, Electrical Engineering and equivalent to meet qualification of manufacturing manager.

Good to have: Repair License of medical device (Category 3 & 5)

Years of Experience:

Generally Requires 8-10 Years Work Experience related manufacturing engineering in medical industry.

Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations :

(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)

・Basic knowledge of instruments and electricity and understanding of repair industry

・Fluent in Japanese & Business level English

・Knowledge of Process Validations (IQ/OQ/PQ) and able to generate protocols and test reports.

・Ability to inspire and develop staff

・Demonstrated project management skills

・Strong verbal communication and listening skills

・Demonstrated problem solving skills

・Strong organizational and project management skills

・Effective communication skills

・Strong writing skills

・Strong computer program skills: Excel, Word, Power Point

・SAP experience and knowledge for managing inventory, stock transfer, order management and BOM kitting

・Effective problem solving and conflict resolution skills

・Innovative and creative; able to motivate and inspire others