Opportunities
Director of Manufacturing - Medical Device
PLEASE NOTE: ISO 13485 EXPERIENCE REQUIRED
Director of Manufacturing - Medical Device (International Assignment)
An innovator in non-invasive medical devices, alternative medicine products and lifestyle consumer electronics is seeking a Director of Manufacturing for our China location. Join an organization with a passion for creating smart, effective, healthy and sustainable devices and products that replace traditional drug and chemical based therapies and solutions.
Position Description:
Key staff member, reporting to in country COO / Vice President of China Operations, who leads electro-mechanical manufacturing and production engineering efforts in alignment with company-wide business and market strategies, product roadmaps, regulatory requirements and general operational procedures.
Display's passion and optimism for company vision while mobilizing others in the fulfillment of the established strategic direction and operational requirements. Day-to-day management and responsibilty for the company's China based OEM and ODM manufacturing. Leads a team of production engineers, assemblers and support staff, building a strong culture of personal pride and company accomplishment within the China manufacturing operations and engineering group.
Operational responsibility and shared budgetary authority for all Shenzhen based manufacturing, manufacturing engineering and facilities management.
A key management team member, sharing goals and cooperating with other department leaders to manufacture and support safe and effective non-invasive medical devices and lifestyle based consumer electronics.
A creative manufacturing engineer and proven project management professional with the leadership ability to unite international manufacturing engineering efforts and promote a cooperative and productive work environment.
SUBMISSIONS WITHOUT COVER LETTER, AVAILABILITY AND
SALARY EXPECTATIONS WILL NOT BE CONSIDERED
Duties and Responsibilities:
A key manager engaging with Executive Management to set strategic direction for foreign manufacturing, production engineering and facilities management functions. Serves as second-in-command to COO - VP of China Operations for manufacturing and production engineering efforts, leading the day to day operations of these activities including:
- Developing and overseeing a ISO 13485 - cGMP compliant electro-mechanical
assembly facility.
- Managing manufacturing engineering staff and activities.
- Production planning, resource loading and management.
Champions implementation and ongoing maintence of cGMP and ISO 13485 systems and procedures for product manufacturing.
Leads and shares budgetary responsibility (with COO and CFO) for facility and infrastructure management in support of Shenzhen manufacturing efforts.
Cooperates with and shares goals with Sales, Marketing, Design and Quality Engineering in the timely scoping, development, delivery and support of new and ongoing product offerings.
Cooperates and shares goals with Sales and USA Operations 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, participates in, holds budgetary responsibility for and cooperates with Regulatory Affairs in the timely and accurate completion of facililities certifications.
Desired Skills & Experience
Master's degree in Manufacturing Engineering or equivalent and PMP certification preferred.
Minimum 7 years related experience and/or training or equivalent combination of education and experience.
Minimum 5 years manufacturing management experience (electro-mechanical device experience preferred) including leadership of foreign manufacturing for regulated products, manufacturing engineering and quality engineering departments or activities.
Minimum 3 years ISO 13485 and/or cGMP manufacturing experience required.
Proven ability to scope, document, resource load and manage the manufacturing and production engineering of electro-mechanical devices in compliance with cGMP and ISO 13485 requirements.
Excellent analytic problem-solving skills.
Superb written and oral communication skills.
Excellent computer skills, specifically Microsoft Office; ERP / MRP / Production Management Software; Knowledge of electronic and mechanical CAD / CAM Software (High level of competence in either or both Mechanical or Electrical engineering and design software).
If interested in this opportunity, please submit a resume and cover letter with salary requirements. The company offers a competitive benefits plan including health and dental insurances.
Company Description
An innovator in non-invasive medical devices, alternative medicine products and lifestyle consumer electronics is seeking a Director of Manufacturing for its Shenzhen, ISO 13485, manufacturing facility. Join an organization with a passion for creating smart, effective, healthy and sustainable devices and products that replace traditional drug, surgical and chemical based therapies and solutions.
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