Plans, directs, and implements all aspects of the company’s design sign and development of new medical device products or software systems.
May develop, evaluate, implement, and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
Oversees the investigation and evaluation of existing technologies. Guides the conceptualization of new methodologies, materials, machines, processes, or products.
Directs the development of new concepts from initial design to market release. Manages feasibility studies of the design to determine if capable of functioning as intended.
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 to the company.
- Coordinates process development documentation and qualification activities related to new product implementations and current products.
- 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. Quality Responsibilities
- Ensures the quality policy is understood, implemented, and maintained at all levels of the organization. • Ensures the quality systems requirements are effectively established and effectively maintained.
- Reports any observed or informed process and/or product non-conformities to the Supervisor.
- Reports any complaint regarding a product to the Supervisor.
- Finds resolution of Quality situations at the area of responsibility.
- Complies with all the requirements in the operational procedures at the area of responsibility in order to meet the requirements of all applicable Quality System regulations (e.g.: FDA Part 820 Quality System Regulation, ISO 13485 Quality Standard, R-PAL (Japanese QSR’s). EHS Responsibilities
- Ensures that EHS MS is effectively implemented and maintained within the area of operations. Provides visible demonstration of his/her commitment, including visiting and inspecting site, participating in incident/accident investigation, participation at EHS meetings and issuing messages of support.
- Provides adequate resources for the maintenance and corrective actions of the EHS.
- Participates in the definition of EHS objectives and targets for the area and ensure that they enhance continual improvement.
- Ensures the personnel are appropriately trained to carry out job activities in accordance to the EHS requirements, objectives and targets.
- Leads continual improvement projects to reduce, minimize or eliminate EHS aspects/impacts within his/her area of operations.
Engineering or Science of Engineering or related field. Experience Manager Level: 7+ Years with bachelor’s or 5+ Years with Masters. 3+ years of experience providing work direction and leadership to people and teams