Position Summary:

Oversee the Manufacturing processes and associated projects such as manufacturing, improvement, validation, and support of these processes for production of medical devices. Scope of responsibilities includes providing comprehensive technical advice for processes of assembly. Also includes medical device demo & loaner units management.

Duties and 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

Fortive Corporation Overview

Fortive's essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We're a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact.

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference.

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone.

At Fortive, we believe in growth. We're honest about what's working and what isn't, and we never stop improving and innovating.

Fortive: For you, for us, for growth.

Ready to move your career forward? Find out more at

Come join our team at Advanced Sterilization Products (ASP) and be part of a global leader in infection prevention solutions for the healthcare industry. With advanced products, technologies, and workflows for medical sterilization and disinfection, ASP is dedicated to defending the lives of patients, families, healthcare workers, providers, and communities. Add your talent to our extraordinary team and help us in our mission to make healthcare safer for everyone. ASP is based in Irvine, California with core sites in Everett, Washington and Schaffhausen, Switzerland plus many more offices around the world.

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