JOB OVERVIEW:

This position is responsible for aspects of the product design and development with a focus on

innovative medical devices that address the customer needs for a complete procedural solution.

The Laser Process Engineer plans, organizes and executes projects 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 Laser team to develop and design processes for components used in catheters

and delivery systems.

• Develop concepts, designs and details for machines, tools and fixtures.
• 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 team.
• Interface between external vendors and core team.
• Develop specifications, engineering blueprints and detail drawings.
• Resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
• Provide design changes for existing products. Ensures proper documentation of changes.
• Create engineering designs, develop plans and keep laboratory notebooks on all work.
• Assist with testing; 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 needed.

SUPERVISOR RESPONSIBILITIES:

The position does not have supervisor responsibilities.

QUALIFICATIONS:

• Bachelor's Degree in Mechanical, Industrial, Manufacturing, Biomedical Engineering or

equivalent is preferred.

• Must have three (3) plus years' relevant Engineering experience.
• Knowledge of laser processing preferred.
• Knowledge and experience in catheter design, development, and manufacturing process.
• Experience with CAD software such as AutoCad or Solidworks is required.
• Knowledge and experience in development processes and in documentation writing is
• required.
• Experience with statistical analysis and design of experiments (DOE) preferred.
• Ability to use PC and associated software is required.
• In-depth knowledge of material and metals is preferred.
• Knowledge of Good Manufacturing Process and Good Documentation Practice.

COMPETENCIES: 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 fingers. 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 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

protection.

TRAVEL:

This position may require 10-25% travel between sites and customer or supplier locations

as required, depending 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.