Supporting manufacturing and investigating non-conformances.
Cycle time, Yield and Process Flow improvement experience
Documentation - BOM, Work Instructions, visual aids, MP, change order documentation.
Education Required: Bachelors Degree or Masters Degree in Mechanical, Manufacturing Engineering, and Industrial engineering.
Years' Experience Required: 3 years in medical device
Responsibilities may include the following and other duties may be assigned.
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan.
Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
Ensure processes and procedures are following regulations.
Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional assignments.
Innovation and Complexity: Problems and issues faced are general and may require an understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve the effectiveness of the job area.
Responsibilities may include the following and other duties may be assigned.
Responsible for production support engineering with respect to testing methods, procedures, and problems; device specification and yield problems; minor redesign of devices and masks; analysis of customer returns; supplier related engineering changes and optimizing device production relative to cost constraints.
Assumes responsibility for device and/or internally produced or externally purchased components after transfer into high volume production and usually responsible for entire device manufacturing operations other than wafer fabrication.
May assist customer in device usage problems or customer testing of complex devices.
TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.
DIFFERENTIATING FACTORS
Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues in order to inform, gain input, and support decision-making.
Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in Support Career Stream.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within the job area typically obtained through advanced education combined with experience. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience.
PHYSICAL JOB REQUIREMENTS - The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)