JOB OVERVIEW

This position is responsible for aspects of the product design and development of a project with a focus on innovative medical devices that address the customer needs for a complete procedural solution. The engineering manager plans, organizes and directs engineering staff to meet company objectives for design, new product development and improvement of existing product lines by performing the following duties personally or through subordinates. This role complies to FDA QSR (21 CFR 820), ISO 13485 requirements and adheres to the Quality Management System (QMS).

ESSENTIAL FUNCTIONS:

• Support R&D team to design and test catheters and delivery systems
• Develop concepts, designs and details for machines, tools and
• Support includes overall design, design for manufacturing, test method development, and product verification and validation testing
• Participate in technical discussions and decision making with cross functional
• Interface between external vendors and core
• Develop specifications, engineering blueprints and detail
• Resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
• Provide design changes for existing Ensures proper documentation of changes.
• Create engineering designs, develop plans and keep laboratory notebooks on all
• Assist with testing (Bench, V&V, in vivo); develop and utilize test protocols; generate written reports.
• Travel to customer sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activities.
• Responsible for supporting design reviews and pre-validation assessments to ensure the safe and environmentally sound processes and designs.
• Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
• 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 not have supervisor responsibilities.

QUALIFICATIONS:

• Bachelor's Degree in Mechanical or Biomedical Engineering is
• Master's Degree in Mechanical or Biomedical Engineering is
• Must have three (3) plus 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 body. Sedentary work involves sitting most of the 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