JOB OVERVIEW

This position is responsible for aspects of the process design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

ESSENTIAL FUNCTIONS:

• Designs fixtures, tools, and machines used to manufacture
• Oversees the development of new processes, methods, and production
• Maintains knowledge of new and developing manufacturing technology, equipment, and applications; applies this knowledge to recommend and implement new technology and processes.
• Perform engineering and data analysis for activities such as validations and engineering studies including DOEs and root cause investigations.
• Generate and review process documentation including but not limited to Manufacturing Process Instructions (MPI), Bill of Materials (BOM), and Lot History Records (LHR).
• Generate and execute Engineering Change Orders (ECO).
• Identify and implement process improvements to increase quality, capacity, and efficiency, while reducing waste.
• Monitor process performance using Statistical Process Control (SPC), and other engineering principles.
• Communicate with customers to understand project needs and set expectations for
• Reviews production program equipment, hardware, and tooling; make recommendations for repairs or replacement.
• Installs new equipment and ensures that it operates correctly; train others to operate new machinery.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.
• Responsible for communicating business related issues or opportunities to next management level.
• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Performs other duties assigned as

SUPERVISOR RESPONSIBILITIES:

The position does have supervisor responsibilities, is responsible for performance management and the hiring of the employees that are designated under their supervision.

QUALIFICATIONS:

• Bachelor's Degree in Mechanical Engineering, Biomedical Engineering, or related field is
• Master's Degree in Mechanical or Biomedical Engineering or related field is
• Must have one to five (1-5) years' relevant Engineering experience
• Knowledge and experience in catheter design is
• Experience with CAD software such as AutoCad or Solidworks is
• Knowledge and experience in development processes and in documentation writing is
• Experience with statistical analysis and design of experiments (DOE)
• Ability to use PC and associated software is
• In-depth knowledge of material and metals is
• Knowledge of Good Manufacturing Process and Good Documentation

COMPENTENCIES: To perform the job successfully, an individual should demonstrate the following competencies:

• Values: Integrity, Accountability, Teamwork, Innovation
• Excellent verbal and written communication skills
• Ability to work independently
• Ability to manage tight timelines and changing priorities
• Excellent problem -solving techniques
• Proficient with Microsoft office applications
• Skilled at providing technical leadership on cross-functional teams

PHYSICAL DEMANDS AND WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS

• Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
• Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human Sedentary work involves sitting most

of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

• Visual Acuity - The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.

WORK ENVIRONMENT

• Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work). The performance of this position may occasionally require exposure to the manufacturing areas, which may require the use of personal protective equipment such as, gloves, frocks, hair and beard covers, face protection, foot protection, safety glasses with side shields and mandatory hearing

TRAVEL:

This position may require 10-25% travel between sites and customer or supplier locations as required, dependent on the needs of the organization

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice