Join our team in Mounds View, MN, where you will be part of a dynamic environment focused on innovation and quality in the field of cardiac surgery perfusion products. We are seeking a dedicated individual to contribute to our mission of advancing technology and ensuring the highest quality standards.
Must Have
- Bachelor's Degree in Engineering, Science, or a technical field with 0 years of work experience in Engineering and / or Quality.
- OR Advanced degree in Engineering, Science, or a technical field with 0 years of work experience in Engineering and / or Quality.
Nice to Have
Bachelor's or Master's Degree in Mechanical Engineering, or other related engineering degree strongly preferred.Experience in medical device design and application of test standards.Experience in applying statistical methods to design reliability and process capability.Certified Quality Engineer, Reliability Engineer, or equivalent desired.Strong oral and written communication skills.Effective team player with cross-functional collaboration skills.Excellent presentation skills.Ability to handle multiple tasks / projects and manage priorities accordingly.Working knowledge of appropriate industry standards.Ability to work in a team environment and exert influence without alienating others.Knowledge / basic understanding of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.Responsibilities
Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished materials product.Collaborate with engineering and manufacturing functions to ensure quality standards are in place.Support post-market quality activities including complaint trending, released product manufacturing and design changes, CAPA support, complaint investigations, real-time age testing, and statistical analysis.Ensure corrective measures meet acceptable reliability standards and documentation is compliant with requirements.May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and / or research and development as they apply to product or process quality.Technical Specialist Career Stream
An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers, and / or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems, or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.
Differentiating Factors
Autonomy : Entry-level individual contributor on a project or work team. Works with close supervision.Organizational Impact : Delivers work of limited scope, typically smaller, less complex projects or related activities.Innovation and Complexity : Identifies, defines, and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.Communication and Influence : Communicates primarily with internal contacts within the immediate group. Contacts others to gather, confirm, and convey information.Leadership and Talent Management : N / A - job at this level is focused on self-development.Required Knowledge and Experience : Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)), 0 years of experience required.