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Our start-up medical device client is developing a novel trans-catheter device used to treat mitral regurgitation and is looking to add a Principal R&D Engineer to their team. The Principal Engineer will work collectively with Product Development, Manufacturing Engineering, and Quality groups to gather data to support design verification and validation for the company’s products using internal and external testing labs. This role includes extensive focus on FEA/CFD. Your role with the....


Our start-up medical device client is developing a novel trans-catheter device used to treat mitral regurgitation and is looking to add a Principal R&D Engineer to their team. The Principal Engineer will participate in the selection of an overall concept and development of a full product development cycle as it relates to the company’s products. This individual will be responsible for a portion of test method development and coordination of testing within internal and external testing....


Our well-funded start-up with a truly novel technology is treating a disease state with several unmet needs is adding 3 Clinical Research Associates to their team! The CRA assists with the planning and development of high quality clinical activities to support projects. The CRA has clinical research experience, and an understanding of research methodology, regulations and guidelines. Ideally, will have experience assisting with the development of clinical strategies and/or plans, protocol....


Our client, a small clinical trial stage company was acquired by an international billion dollar medical device company. They are adding 5 Field Clinical Specialist/Engineers to their team. The FCS/FCE will be responsible for day-to-day field implementation of companies multi-center clinical investigations in accordance with corporate objectives, EU and FDA guidelines and protocols. The Field Clinical Engineer (FCE) is the primary site contact with respect to study recruitment, patient....


Our mid-sized, private equity-backed global client is adding a Principal Clinical Affairs Specialist. The candidate will be working with life-saving medical device technology development and commercialization. The company has a rich history of innovation as well as a recognizable brand in their segments of the industry. This global business sells their products directly in addition to utilizing a wide array of distributors around the world. With a strong platform, new products under....


Our mid-sized global medical device client provides proprietary, innovative technologies to specialty markets. Their products are designed to increase treatment efficiency, lower patient risk and provide customer value. They are looking to add a Regulatory Affairs Manager to their team. Your role with the company:Manage the daily operations of the Regulatory Affairs which includes managing three RA Specialists.Prepare and review 510(k) and PMAs and PMA supplements for new and broadening of....


Our mid-sized medical device client is adding a Sr. Clinical Research Associate and a Clinical Research Associate to their team. The Sr. CRA will be managing the CRO and Core Lab and act as a bridge between the two. This is a very exciting opportunity to be part of an early stage IDE pivotal clinical trial! There will be about 500 patients with 60 US sites and 20 OUS. Ideally looking for someone with PMA experience as well as small/mid-sized company experience (no large company entire....


Our growing, mid-sized medical device client is looking for a Senior Electrical Engineer. This person will be responsible for the design, development, testing, and refinement of electrical systems and tools. The Sr. Engineer will provide strong technical leadership on new product development projects while assisting in sustaining currently manufactured products. Your role with the company: Lead the design and development of electrical components within current portfolio and expanding product....


Our well-established medical device client is looking to add a Clinical Research Manager to their team. The manager will be responsible for management of all clinical activities related to one or more clinical studies. This may include performing and/or overseeing the daily in-house operations associated with the studies. Independently handle various clinical study assignments. Manages clinical team assigned to these clinical studies to ensure studies are conducted to meet business objectives....


Our 30 person global supplier for the medical device industry is hiring an Extrusion Engineer to provide engineering support to Extrusion, Second Operations and Development to develop new products and implement process improvements (cost reduction, quality improvement, reduce downtime, improve tooling & equipment, etc.). This position is also responsible for designing and developing new tooling and bringing them into mass production. Your role with the company: Lead new technology and....


Our mid-sized medical device client is adding two Sr. Regulatory Affairs Specialists to their team. Due to recent acquisitions, this is an exciting time to be part of the team! Bring your experience in the medical device industry with you to explore this fascinating company, be part of the integration, and play a role in these trail-blazing opportunities.Our client partners with the world's leading and emerging medical device, diagnostic and life sciences companies to develop and commercialize


Responsible for coordinating all activities necessary for on-time delivery of tooling projects that meet 1) most efficient manufacturing practices, 2) meet customers fit, form and function requirements, 3) best cost trade-off for needs and 4) tooling integrity over life of the project. Constant internal contact with sales, estimating, manufacturing, quality assurance, and tooling services. Work with supplier and customers require tact, resourcefulness and a working knowledge of Company....


Our start-up medical device client is developing a novel transcatheter device used to treat mitral regurgitation. This is a new position where the Principal Engineer will participate in the selection of an overall concept and development of a full product development cycle. In addition, this individual will assist the Director, Product Surveillance in developing infrastructure related tools as it relates to all companies programs. Your role with the company:Participate in the design and....


Our mid-sized medical device client is adding a Clinical Project Manager to their team. They are actively enrolling their IDE pivotall clinical trial (around 500 patients 60 US sites and 20 OUS). Need someone who has managed CRO's and core labs as well as CER experience. Will be overseeing data and identifying risks. Small/mid-size company experince needed. The Clinical Project Manager leads the planning, development and execution of the clinical research project(s). Ensures compliance to....


The purpose of this position is to ensure the sustained competitiveness of company by supporting efforts to continually strive for improving quality process efficiency and effectiveness, as well as positively profitability, safety, production, delivery and enhance customer satisfaction. Ensure adherence to defined quality standards and company’s documented process. WORK PERFORMED: Work with Manufacturing and Process Engineers, Quality Technicians and Inspectors, and Operations to resolve....


Establish molding parameters for prototype, existing and new tooling. Establish scientific processing methodology that keeps company current with latest methods. Develops and mentors technical group in the manufacturing area. Position involves contact with a very wide range of individuals inside and outside the Company where matters discussed require processing knowledge, resourcefulness, tact, and a thorough working knowledge of Company policies, practices and procedures. They are a strong....


Our 30 person global supplier for the medical device industry is expanding and in need of a Manufacturing Manager. The Manufacturing Manager will be responsible for providing direction, strategy, management, and execution in the development and manufacture of customer’s products per customer’s requirements in an ISO 13485 environment while maintaining or exceeding organizational metrics. POSITION RESPONSIBILITIES Coordination of manufacturing, warehouse, shipping and receiving activities to....


Prepare and submit regulatory submissions to Regulatory Authorities e.g. the FDA, (for PMAA, IDE, 510(k) Notification); and to European notified body to support distribution and marketing objective set by divisional and corporate staff.Inform project teams of new and changing regulatory requirements.Update RA procedures as needed to ensure company is in compliance with new and changing regulatory requirements.Keep abreast of new and changing regulatory requirements.Review and approve....


The Clinical Research Specialist will work with clinical & health economic research managers and senior marketing staff to develop and communicate evidence to demonstrate clinical and economic benefits of companies products to the users and purchasers. DUTIES AND RESPONSIBILITESProvides balanced reviews and reports of clinical safety and performance to internal and external stakeholders. The Clinical Research Specialist ensures compliance with clinical and regulatory standards and....

- Mpls, MN

Plan, organize, lead, and control the activities of Production Supervisors and their direct reports to ensure production operations reach and sustain a globally competitive position and achieve short-term and long-term business plan goals. The primary focus is the on-time delivery of quality product at or below estimated cost. Lead by example and set a high standard of performance for self and those people he/she leads. An exceptionally high level of effective cross-functional collaboration is

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