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Our mid-sized medical device client has a small office in the southwest suburbs and they are looking to add a Sr. Regulatory Operations Specialist to their team! This person will have the opportunity to work remote 2 days a week. They have doubled revenue in 36 months. This will be a great opportunity to learn new things and gain new experiences in a smaller, more nimble company This position will be responsible for analyzing and supporting/resolving functional business issues and needs, as....


Our smaller medical device client is adding a Sr. Clinical Research Associate to the team. They are driven to improve and extend the life of patients suffering from neurological diseases by providing an innovative technology for patients with neurological diseases. The Sr. CRA will work with the Clinical Study Manager to satisfy applicable regulatory standards and internal requirements for worldwide clinical studies. Bridges the responsibilities of the Clinical Study Coordinator and the....


Our 12-person fully financed neuro start-up client is adding their first Regulatory Specialist to the team! The Sr/Principal Regulatory Specialist will manage and perform regulatory activities for obtaining product approval/clearance within the organization. This role will be primarily responsible for the preparing of U.S. and global (as applicable) regulatory submissions and will work closely with other core team members across the organization. Your role with the company: - Develop and....


Our 15-person, start-up medical device client is developing a novel, minimally invasive technology for structural heart disease. The team is adding a Principal Design Assurance Engineer who will report to the Sr. Director of Quality. The Design Assurance Engineer will be responsible for new product development (conception to launch) and sustaining projects. Lead for the planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design....


Our mid-sized client is adding a Vice President of Global Regulatory Affairs to their team! The VP Regulatory will have multi-site responsibility for developing and leading the regulatory and technical communication strategy to support the product lifecycle of companies products from product development through commercialization. Will provide regulatory insight (raising potential issues/concerns) on business matters, establish and maintain effective relationships with regulatory bodies such as


Our mid-sized client is growing and adding a Sr. Clinical Project Manager to the team! Need to have written clinical protocol's independently and written a protocol from start to finish. This person will be reporting to the Sr. Clinical Manager. Your role with the company:Development of clinical study protocols and ensuring clinical compliance in the conduct of clinical studies. Reviews clinical data, provides direction on analysis of data, and develops clinical study reports with high....


Our mid-sized medical device client has a small office in the southwest suburbs and they are looking to add a Regulatory Specialists. This person will have the opportunity to work remote 2 days a week. They have doubled revenue in 36 months. This will be a great opportunity to learn new things and gain new experiences in a smaller, more nimble company.Manage regulatory submissions including registration strategy, timeline and submission coordination, development/review of documentation,....


Our 10-person, start-up medical device client is developing a novel, minimally invasive technology in the Twin Cities. This is a newly created position and will be the only Clinical Project Manager reporting to the Director of Clinical. Primary Responsibility: * Drafts clinical trial protocol, protocol amendments, and study reports, as directed. * Develops and executes research tracking databases and spreadsheets to provide relevant information for Clinical Studies management. * Manages....

- Minneapolis, MN

The Clinical Science Manager is responsible for the scientific review and publication of data related to the company’s products, technology, and strategy. This person will manage the company’s publication portfolio and external research proposals/grants and assist with scientific data analysis.Primary Organization Responsibilities Establish a publication/presentation strategy that meets the needs of external and internal stakeholders and manage the project timelines for generation of....


Our early stage medical device manufacturing start-up client is adding a Systems Engineering Director/VP to the team. The hands-on manager will provide interdisciplinary research and product development leadership from inception through pilot production. He or she must be able to work effectively with all functional groups to define system-level requirements and resolve cross-functional issues. Your role with the company: Define, plan, and execute development programs to implement design....


Our 12 person small R&D facility is adding a Sr/Principal Product Development Engineer to the team. The medical device company develops and manufactures minimally invasive, single-use medical devices in the endoscopy, cardiovascular, neurovascular, and urology markets. The products they develop and manufacture are typically market disruptive and displace higher cost procedures. Your role with the company:Work collaboratively with other engineers and personnel from client companies assigned


Our client, a small clinical trial stage company is adding a Sr. Regulatory Affairs Specialist to their team. The Specialist will engage in planning and execution of global regulatory activities necessary to support implementation of clinical trials and subsequent commercial distribution of companies products. This position will provide regulatory functional representation and review of documentation related to clinical trials, labeling, design and specification, and manufacturing processes,....


Our very early stage medical device start-up client is adding a Quality Technician to their team! Since they are a small company they are looking for a self-motivated person that likes wearing lots of hats and is willing to help with any task needed. Your role with the company: Oversee cleanroom activitiesDocument Control activitiesEstablish and maintain Device History RecordsGenerate and process documentation through the Change Order SystemTest method developmentWork with Engineering to....


Our mid-sized, growing client is looking to add a Sr. Mechanical Engineer to the team. The Sr. Mechanical Engineer is responsible for the design and development of mechanical systems in the companies product line. This individual will bring previous mechanical experience and well as develop new skills in the integration and development of technology of future products as well as the continuous improvement of the current product line.Your role with the company:Prepares recommendations for the....


Our growing, mid-sized client is looking for a Verification & Validation Engineer! The Engineer will perform essential engineering duties in planning and designing imaging products. Your role with the company:Analyze functional, clinical, and system specifications to ensure all requirements are testableCreate detailed Verification and Validation (V&V) test plansDevelop, coordinate, and execute Design Verification Test (DVT) protocol and prepare test summary reportsDesign test methods....


Our mid-sized medical device client has created a new role for a Clinical Evaluation Report Writer! This role will report to the Director of Clinical and have a lot of visibility to the leadership team and able to make a huge impact on the business. The CER Writer will be responsible for gathering, analyzing, and generating global clinical evidence for both the Ortho/Spine areas. Support of development of regulatory clinical evaluations, as well as clinical summaries for submissions to....


Our mid-sized medical device client is looking for a Director of Clinical to provide oversight and managment of their clinical department. This person will report to the VP R&D/Clinical. There will be around 5 direct reports including a Sr. Manager of Clinical. There are a number of new products in development and the clinical studies will be conducted in the US and OUS. Your role with the company:Direct and set strategy for managment of clinical studies includingPreparation of study....


Our client, a small clinical trial stage company was acquired by an international billion dollar medical device company. They are a fast paced, fail fast R&D organization that is dedicated to providing the best solution to the market. Their technology is a unique Nitinol based design and it is addressing major unmet needs in the market. As a result, they are looking for high impact, self-starter, agile individuals who value creativity, learning and data above all else. Their current need....


Our client, a small clinical trial stage company was acquired by an international billion dollar medical device company. They are a fast paced, fail fast R&D organization that is dedicated to providing the best solution to the market. Their technology is a unique Nitinol based design and it is addressing major unmet needs in the market. As a result, they are looking for high impact, self-starter, agile individuals who value creativity, learning and data above all else. One of there current


Our 15 person, start-up medical device client is developing a novel, minimally invasive technology in the Twin Cities. This is a newly created position and will report into R&D. The company recently received close to $20 million in VC financing. Your role with the company:Build prototype and clinical use catheter delivery systems, while providing design feedback to R&D Engineering.Neatly and accurately complete device history records, as well as keep an accurate and up-to-date....

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