Project Engineer Intern (Medical Devices)

Job Description

Salary:

Purpose

The Project Engineer Intern will support medical device team with existing and new products with development and management. This will include assembly, testing, and marketing as well as equipment management associated with products.

Responsibilities

Support development of new products as additions to the company portfolio in conjunction with Technology, Quality Assurance, and Operations departments

Develop manufacturing processes of new products with focus on repeatability and practicality in conjunction with Quality Assurance and Operations departments

Author/revise procedures according to FDA 21 CFR 820 and other regulations (as appropriate)

Follow design control procedures throughout product life cycles

Assist in prototyping and assembly of device concepts

Support the development and implementation of sales material for products and work with Quality to ensure all claims are appropriate for market and regulatory position

Assist in the readiness of the companys existing products including facility, equipment, and process specific tools

Design, order, evaluate, and onboard new proprietary equipment in support of manufacturing. Assist in equipment and supply onboarding and maintenance/calibration

Assist design and performance of validation protocols in accordance with regulatory requirements and industrys best practices

Assist with training and technology transfer for new projects and products

Assist with investigation of quality events and determine appropriate containment, preventive/corrective actions

Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures.

Assist in the development and maintenance of project schedules and execution of assigned task items

Assist with the execution of associated project validations (process validation, sterilization validation, packaging validations, etc.)

Assist with the design of product labels to support distribution and product launches in accordance with regulatory requirements

Complete required hours on assigned duties works shift to complete assigned responsibilities and duties

Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes

Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs when necessary

Perform other duties as assigned

Skills

Ability to create simple CAD designs

Ability to work independently and in a team environment

Excellent attention to detail and organization

Excellent written and verbal communication

Highest level of ethics and integrity

Ability to lead and motivate the right behaviors

Ability to multi-task and work in a fast-paced environment

Strong technical writing

Effective project management

Proficiency in Microsoft Office

Qualifications/Requirements

Bachelors degree (or current enrollment) in an Engineering or related field required

CAD software experience preferred

Mechanical Design experience preferred

Entry level position

Clearance of favorable background investigation required.