Custom Search Inc.
Principal Systems Test Engineer
11/8/2024
Minneapolis, MN
Direct HireOn-Site
Our mid-sized cardiovascular medical device client is seeking a permanent Principal Systems Test Engineer to join their team. This is a key technical leadership role responsible for leading the development and execution of comprehensive testing strategies. Responsible for evaluating, developing, and implementing test systems/tools/equipment, including design documentation. The position will provide Verification and Validation expertise to new product introduction of electro-mechanical, software-controlled medical devices. This role requires a deep understanding of medical device systems, strong leadership abilities
Sr. R&D Sustaining Engineer
11/8/2024
Minneapolis, MN
Direct Hire
Our mid-sized medical device client is adding a Sr. Sustaining Engineer to the team. This is a newly created position reporting to the Director of Quality. The Sr. Sustaining Engineer will be primarily maintaining existing commercialized products post transfer by ensuring the products remains safe, compliant and optimized for manufacturing process performance. There will also be an opportunity for some Design Assurance engineering support for products in development by driving and executing risk management and design control activities. This
(2) Sr. Clinical Research Associate
11/5/2024
St. Paul, MN
Direct HireHybrid
Our small start-up client is adding 2 (Sr.) Clinical Research Associates (CRA) to the team. The CRA works as part of the clinical team to ensure the completion of company-sponsored clinical studies.  As an internal and externally facing position, this position interacts directly with the internal study team, clinical vendors, clinical Investigators, and other study staff at a clinical research site.  The CRA will be the primary contact for the study sites regarding the proper execution of the
Principal Electrical Engineer
11/4/2024
Minneapolis, MN
Direct HireOn-Site
Our mid-sized cardiovascular client is adding a Principal Electrical Engineer to the team. The EE will play a key role in supporting and improving designs of innovative medical devices. This is a technical, hands-on engineering position that works as an integral member of the design-sustaining team.  In this role, you will utilize data to identify opportunities, lead projects, and implement changes focused on improving product performance and reliability, product enhancements, and component obsolescence. You'll be a
Sr. Design Assurance Engineer
10/30/2024
Minneapolis, MN
Direct HireOn-Site
Our mid-sized medical device client is adding a Sr. Design Assurance Engineer to the team! The Sr. Design Assurance Engineer utilizes risk management and quality planning activities to provide quality engineering support of product/process development and input to Quality Management Systems affecting product/process development. Champions departmental or cross-functional engineering initiatives and acts as an effective leader or team member in supporting quality disciplines, decisions and practices. Your role with the company: Key member of medical device development project
Clinical Project Manager
10/25/2024
Minneapolis, MN
Direct HireFull Remote
Our small, well-funded start-up client is adding a Clinical Project Manager to the team.  The Clinical Project Manager will report to the VP Clinical (lives in MN) and will be a remote role with minimal travel. The Clinical Project Manager leads the planning, development and execution of the clinical research trial(s). Ensures compliance to study protocol, Good Clinical Practices, applicable domestic and international regulatory standards, and Standard Operating Procedures. The Clinical Project Manager will participate in development
Product Development Engineer 3
10/21/2024
St. Paul, MN
Direct Hire
Our mid-sized medical device client is looking for a seasoned engineer. The Product Development Engineer III with a mechanical focus, is responsible for development and implementation of new products, developed jointly with Process Development and Manufacturing Engineering, into full production, as well as supporting of continuation engineering on existing product lines. The role will be about 70% Project Management with about 30% technical. Your role with the company: Product Concept: *Basic understanding of customer/user and patient needs. *Proposes concepts
Sr. Upstream Product Manager
10/11/2024
Minneapolis, MN
Direct HireHybrid
Our mid-sized medical device client has an exciting career opportunity in the Global Upstream Marketing team for a Senior Upstream Product Manager reporting to the Director of Global Upstream Marketing. You will have global responsibility for product marketing deliverables for new products, from opportunity assessment through the product development process to commercial launch. By understanding the markets, customers, and competitors, you will build business cases and define project scope for new products supporting business goals. You will help achieve
Clinical Study Manager
10/11/2024
Minneapolis, MN
Direct Hire
Our mid-sized medical device client is adding a Clinical Study Manager to the team! The Clinical Study Manager will report to the Sr. Clinical Manager and will oversee clinical activities related to one or more clinical studies and performing/managing the daily in-house operations associated with the studies. The Clinical Study Manager will work independently on multiple complex clinical studies using critical thinking skills. Will be managing one study in start-up and another on-going study. The new
Sr. International Regulatory Affairs Specialist
10/7/2024
Minneapolis, MN
Direct HireHybrid
Our mid-sized medical client is adding a Sr. Regulatory Affairs Specialist to their team! The Sr. Regulatory Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed.  The Sr. Regulatory Affairs Specialist will perform regulatory submission/approval activities for all products and ensures compliance with required regulations and established corporate standards. Your role with the company: Preparing documentation for international regulatory registrations Preparing technical documentation
Clinical Research Associate/Sr. CRA
10/7/2024
Minneapolis, MN
Direct HireHybrid
Our mid-sized medical device client is adding a Sr/Clinical Research Associate to the team. The Sr. CRA is responsible for the initiation and oversight of clinical centers to ensure the successful conduct of active clinical studies. The Sr. Clinical Research Associate will ensure that clinical centers perform the clinical study according to the study protocol and regulatory standards by qualifying, training, monitoring and overseeing study conduct at multiple clinical centers. Your role with the company: Identify and assess the
Sr. Clinical Research Associate
8/26/2024
Minneapolis, MN
Direct Hire
Our early stage start-up client is adding a Senior Clinical Research Associate to the team. The Sr. CRA assists with the planning and development of high-quality clinical activities to support projects. The Sr. CRA has strong clinical research experience, and a strong understanding of research methodology, regulations, and guidelines. The Sr. CRA has experience assisting with the development of clinical strategies and/or plans, protocol development and execution, monitoring, and ensuring data quality and management of clinical studies. The
Regulatory Specialist
8/11/2024
Minneapolis, MN
Direct HireHybrid
Our mid-sized client is adding a Regulatory Affairs Specialist to join their team. The Regulatory Affairs Specialist will support international registrations and renewals. This individual is responsible for ensuring product approvals are properly maintained, and product re-registrations are properly managed.  The Regulatory Affairs Specialist will perform regulatory submission/approval activities for specific products and ensures compliance with required regulations and established corporate standards.   Your role with the company:   Preparing documentation for international regulatory registrations and renewals. Defining worldwide regulatory
Director of Electrical and Software Engineering
8/11/2024
Plymouth, MN
Direct Hire
Our smaller medical device client is adding a Director of Electrical and Software Engineering to lead an engineering team in creating groundbreaking solutions. The Director of Electrical and Software Engineering will play a pivotal role in driving the development and implementation of electrical and software systems for innovative medical devices. This leadership position requires a seasoned professional with a proven track record in both electrical and software engineering, as well as a deep understanding of regulatory requirements within the medical
Sr. Quality Engineer
5/30/2024
Minneapolis, MN
Direct HireOn-Site
Our mid-sized medical device client is adding a Senior Quality Engineer to the team! The Sr. QE will have the opportunity to be a key team member in supporting a medical device from transfer to manufacturing through commercial distribution. They are responsible for ensuring a smooth transition of new products to the manufacturing floor with the assistance of a cross-functional team. They will maintain oversight of all manufacturing activities and be responsible for the final release of sterile

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