Senior Sustaining Engineering Manager (Medical Device) - Coyote Technical & Executive Sourcing

Senior Sustaining Engineering Manager

Position Summary

Evaluate and ensure manufacturing engineering operations can have a steady and robust supply of all components required to maintain daily production. This includes planning and implementing any work necessary to address supplier changes to efficiently implement and sustain supply.to produce products and develop processes to ensure quality, cost and efficiency requirements. This also would include projects required to implement regulatory changes and/or development of alternate critical suppliers to ensure continuous supply. Lead and manage key process items to bring reduce overall product/component cost and improve efficiency of manufacturing operations.

Key Accountabilities:

Lead Sustaining Engineering team for existing and new products. Ensure suppliers are assessed and highest risks are identified and addressed to ensure the most robust component supply possible. Develop strong relationships with TAS suppliers and support any changes in an efficient and collaborative manner. Ensure new suppliers are robust and financially viable for projected long term growth including support in product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc .Lead the conversion of small-scale processes into commercially viable large-scale operations. Work with Research and Development to develop and transfer new designs to manufacturing Lead DOEs, TMVs and software validation as necessary Support Quality system items such as CAPAs, NCRs, CQPs, TMVs, etc. Establish departmental objectives, organization, equipment and tooling resources and required technical direction. Recommend modifications/improvement where advisable to minimize cost. Develop and maintain yearly departmental budget (Capital & Expense Accounts) Provide primary direction for Quality System implementation, maintenance, training, and facilitation for compliance to quality system requirements for manufacturing and engineering staff .Budget managed (if applicable)- Sustaining Engineering Internal Networking/Key relationships: This position requires cooperating with different company departments, such as Quality, R&D, Regulatory, Operations, Sales, Marketing, Finance and the other team members of the department Minimum Skills and Capabilities :Excellent written and verbal communication.

Understanding of quality system (ISO13485, 21CFR820) regulations Strong leadership skills Ability to interact with all levels within organization. Ability to delegate and motivate subordinate staff. Analytical skills for compiling and analyzing data. Computer and software skills. Understanding of supply chain activities. Problem solver able to think analytically

Minimum Knowledge & Experience required for the position:

4 - year engineering degree or equivalent experience 10+ years of experience in a technical role in the medical device industry

Project management experience in the medical device industry Experience and understanding of quality system regulations (e.g. 21CFR820, ISO13485).

2-3 years Manufacturing / Supervisory experience

5 years of medical device manufacturing Statistical and process controls experience, including experience with Design of Experiments, qualifications and validations.

No sponsorship visa (H1-B, etc) candidates at this time, sorry.


Qualified candidates must submit their resume in Microsoft Word format along with at least three professional references to:


COYOTE TECHNICAL & EXECUTIVE SOURCING
Phil Montoya
Director of Sourcing

Senior Sustaining Engineering Manager (Ft. Lauderdale, FL) - Full-time & Permanent
#MedDevice
#MedicalDevice
#SustainingEngineer
#EngineeringManager
#SouthFLJobs
#Miami
#FtLauderdale
#Jobs