*** PLEASE NOTE THIS POSITION IS BASED IN SHENZHEN CHINA***

Nextern, an innovator in developing and manufacturing class II & III electro-mechanical medical devices, is seeking a Director of Engineering for its Shenzhen China location. This is a position based in Shenzhen China requiring a commitment to relocate for 3-5 years. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions.

This role leads the Nextern engineering and sourcing functions in China, a talented group of engineering professionals who work together to solve problems, reach goals and deliver products that exceed customer expectations. This group measures itself on its ability to be innovative and efficient while delivering top quality parts and products to its medical device clients.

Position Description:

A senior staff member to lead all aspects of the companyngineering and technical sourcing efforts at our growing Shenzhen ISO 13485 assembly facility.

The Director of Engineering has day-to-day oversight of all engineering and technical sourcing functions and shared budgetary authority for all related China based staff, activities and facilities, totaling 10+ employees.

A key management team member, sharing goals and cooperating with other company leaders to develop and manufacture industry leading therapy delivery (catheter and leads) and integrated systems (electro-mechanical) medical components and devices.

A creative and dedicated leader and proven management professional with the ability to direct engineering technical sourcing efforts and promote a cooperative and productive work environment.

• Senior staff member engaging with the Nextern Leadership Team to set direction for design engineering, technical supplier sourcing and management processes and functions.
• Growth and maintenance of a strong and cost competitive supply chain, including locating new sources of supply, developing new capabilities and supporting lean initiatives.
• Cooperates with and shares goals with USA Engineering and Sales in the timely scoping, development, delivery and support of new and ongoing product offerings.
• Cooperates and shares goals with USA Engineering, Sales, Operations and Quality in the timely and accurate quoting and completion of client projects, design transfer and manufacturing activities.
• Cooperates and shares goals with Regulatory Affairs in the timely and accurate adherence to government agency requirements.
• Leads and drives project management for design and transfer to manufacturing for class II & III medical devices in a compliant and efficient manner.
• Oversees the timely transfer of projects into manufacturing from the USA based and China based design teams, ensuring product integrity, design intent and schedule are reached and costs targets are attained.
• Leads the timely and accurate deployment and ongoing adoption of company systems and SOPs including Project Management (Celoxis) and Document Control Systems.
• Champions implementation and ongoing maintenance of cGMP and ISO 13485 systems and procedures.
• Ensures technical management, qualification and engineering direction for sub-tier suppliers.
• Shares budgetary responsibility (with GM, China Controller and CFO) for engineering staff, facility and infrastructure management.
• Leads, participates in, holds budgetary responsibility for and cooperates with Regulatory Affairs in the timely and accurate completion of facilities certifications.

Requirements

• Bacheloregree in Engineering.
• Minimum 7 years related engineering experience with a minimum 3 years of engineering management and/or project management experience.
• Experience with regulated products and highly controlled manufacturing environments operating in compliance with ISO 9000 and/or ISO 13485.
• Understanding of injection molding, metal stamping, forming and casting and electro-mechanical manufacturing processes.
• Strong desire to succeed, meet deadlines and achieve goals.
• Excellent analytic problem-solving skills.
• Superb written and oral communication skills.
• Excellent computer skills, specifically Microsoft Office; CAD/CAM
• Experience in a ISO 13485 / cGMP medical device environment is required.

Benefits

If interested in this opportunity, please submit a resume and cover letter with summary of relevant experience and availability. The company offers a competitive benefits package including health, dental insurance and a travel allowance.

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