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.