Published: November 8, 2017
- May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
- Guides the conceptualization of new methodologies, materials, machines, processes or products.
- Directs the development of new concepts from initial design to market release.
- Coordinates process development documentation and qualification activities related to new product implementations and current products.
- Manages feasibility studies of the design to determine if capable of functioning as intended.
- Plans, directs and implements all aspects of the company’s design and development of new medical device products or software systems.
- Oversees the investigation and evaluation of existing technologies.
- Monitors documentation maintenance throughout all phases of research and development.
- Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
- Leads the Engineering and/or Manufacturing Operations efforts.
- Monitors and reports department metrics, including capacity analysis, machine utilization, cycle time, yield, scrap, FAPC and resource management.
- Executes changes accordingly to assure compliance to plant goals and objectives.
- Leads and coordinates the efforts to enhance the facility infrastructure to assure adequate building and facilities for future production demand.
- Interfaces with F.D.A. during Plant inspections and their official meetings.
- Recommends and supports manpower approbation, facilities and budgets for all functions and assures they are used at highest possible return.
- Provides process and product engineering support to manufacturing in the areas of FRY/CUM yield improvement, failure analysis, yield correlations, streamline of processes, product cycle time, shipping commitments.
- Provides engineering support to product development activities, participates in new products manufacturing / technology reviews to define process capability and feasibility, establish initial and ongoing relationships with product development in evaluating these needs.
- Ensures proper supervision and coordination of technical services and company programs.
- Assists in administrative issues with other facilities and provides technical support for expediting product/process related issues.
- Works to ensure department personnel complies with company policies and procedures, including, but not limited to, QSR, ISO 9002, EEO, ADA, OSHA, EPA, etc.
- Monitors product/process performance metrics and provides timely feedback for investigations and corrective plans (i.e. PRB).
- Manages a cross-functional team of product / process engineers, test engineers, engineering and facility engineers/technicians and industrial engineers.
- Responsible for addressing product performance and reliability issues related to components and their manufacturing facilities.
- Leads yield improvement activities for the manufacturing of EMs and Finishing of devices.
- Creates the annual operating plan (AOP) and capital plan for engineering cost centers. Maintains spending to plan.
- Evaluates performance of direct reports.
- Builds relationships with counterparts at the worldwide manufacturing facilities.
- Establishes systems and processes that are necessary for meeting departmental and company objectives.
- Performs other position related duties as assigned.
- Bachelor’s Degree: Engineering or Science of Engineering or related field.
- Experience: Senior Manager Level: 10+ Years with Bachelors or 7+ Years with Masters. 5+ years of progressive leadership experience in functional area or related field.
- Exposure to engineering and manufacturing environment
- Skills: Talent Management & Development, Interpersonal Relations, Quality and Results Oriented, Computer Literate
- Fluency speaking and writing in English and Spanish
- Experience in medical device, pharmaceutical, or electronic industry (desired)
- EIT license and active member of College of Engineers and Land surveyors (desired)