The Product Quality Engineer Intern will report directly to the Product Quality Engineer and assist with product quality and design assurance deliverables in the development of new medical devices, as well as changes to existing commercialized devices. Experience product risk management throughout entire product lifecycle and help to assure compliance to ACIST design control procedures, applicable regulations and external standards. Provide hands-on technical quality engineering support for new product transitions internally and externally into commercialized production including development of quality requirements/plans, design/process validation requirements, test method validation and ongoing change management for finished device manufacturing. The role works upstream and downstream ensuring the total product lifecycle is maintained and that our products continue to perform as designed.
· Interact with Eden Prairie engineering team to support product development and ongoing sustaining activities.
· Provide quality support for operations, inspection & test activities for products supported
· Support supplier qualifications and ongoing management of contract manufacturers as required.
· Help to ensure that specifications and requirements are relevant, capable, contain essential elements and meet applicable standards, and that all requirements are suitably testable and verified.
· Generate QA deliverables to meet the project scope and plan.
· Review and approve change orders related to product/process changes. Changes include approval of procedures and work instructions for design, manufacturing and inspection.
Training to be provided
Students will be exposed to working with various operations and product development departments within the ACIST organization. They will learn key requirements which need to be followed in a regulated environment such as the medical device industry.
Engineering student enrolled in Engineering Program focused on biomedical, mechanical or electrical engineering through sophomore year coursework.
· Moderate level of computer proficiency including Microsoft Office Suite
· Effective oral and written communication skills
· Detail oriented
· Ability to prioritize and handle multiple tasks
· Demonstrated knowledge and proficiency in problem solving
· Demonstrated knowledge and basic understanding of statistics, data analysis, and reporting of results
ACIST has taken steps to prioritize employee safety & engagement, business health & readiness and customer supply & support, including but not limited to:
- As of November 15, 2021 ACIST & Bracco Medical Technologies will require COVID-19 vaccinations for all employees, interns and co-ops in the United States. Where permitted by applicable law, employees, interns and co-ops must have received or be willing to receive the COVID-19 vaccine by date of hire to be considered for a U.S.-based position, if not currently employed by ACIST Medical Systems.
- Virtual recruitment and virtual and hybrid onboarding where applicable.
- Following CDC guidelines with regard to limiting access to the Eden Prairie office to essential workers and those with special permission to enter the office.
· Eden Prairie, Minnesota
· Summer 2022 (May through August)
· Hours: 40 hours per week