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- Los Angeles, CA
new job!

Regulatory Affairs Project Manager Job – Medical DeviceOur client needs a Regulatory Affairs Project Manager to support Asia Pacific (Japan, China, South Korea and Taiwan) regulatory approvals for implantables. Comfort and experience working hands on with design and validation reports and other technical files is needed.RequirementsPrevious experience authoring or approving design and validation reports a plus (strong technical writing skills).Experience in Regulatory Affairs with US Class III


Our client cannot sponsor or transfer any work visa at this time You must currently live in the USA to apply Position Summary: New product development of medical devices and components through manufacturing scale-up. Responsibilities:Research, develop, and design of new medical devices products and componentsCreate and manage design documentationDevelops validation protocolsWork with manufacturing to bring product into productionSupports sustaining engineering efforts Requirements:MUST HAVE....

- Buffalo, NY
new job!

R&D APPLICATION ENGINEER - INDUSTRIAL GAS - HEALTHCARE - MEDICAL EQUIPMENT - MEDICAL DEVICE Our client, a Fortune 300 company and leading global supplier of atmospheric gases and equipment is seeking a Healthcare Applications Engineer based out of their state-of-the-art Technology Center for global plant engineering and research and development. SCOPE: As a member of the Healthcare Applications team, the successful candidate will work with the regional healthcare business leaders to....

- Sturgis, MI
new job!

A manufacturer of plastic injected molded medical and aviation components is seeking a Process Technician for their operation. This facility is located in southwest Michigan and close to South Bend and Elkhart Indiana and Kalamazoo and Portage Michigan. Basic Role Using SIM technology, install and remove molds and process and trouble shoot molds to produce quality parts, follow and maintain ISO procedures, initiate preventive actions to prevent non-conformity product, follow 5S requirements,....

- Sturgis, MI
new job!

A manufacturer of plastic injected molded medical and aviation components is seeking a Quality Engineer for their operation. This facility is located in southwest Michigan and close to South Bend and Elkhart Indiana and Kalamazoo and Portage Michigan. Basic Role The basic role of this position is to develop the quality protocols for new product validation and process qualifications. This would include the development of controls plans, equipment calibration, working with suppliers and....

- Sturgis, MI
new job!

A manufacturer of plastic injected molded medical and aviation components is seeking a Manufacturing Engineer for their operation. This facility is located in southwest Michigan and close to South Bend and Elkhart Indiana and Kalamazoo and Portage Michigan. Basic Role Plan, install and integrate equipment into the production system. This would include electrical, mechanical, hydraulic, automation and pneumatic systems. Other roles: programming PLCs (AB) and vision systems, working with CAPA....

- Elmsford, NY
new job!

Senior Clinical Trials Project Manager Elmsford, NY or Glasgow, DE (Relocation Provided) Competitive Pay, Bonus, 4 weeks PTO, 6% 401K, Great benefits We have a new opening for a Senior Clinical Project Manager with a longstanding client; a multi-billion ($8B+) global medical diagnostics/instrumentation company. They have strong revenue growth, a stable environment, very low turnover, and offer the opportunity to work on customized, complex medical products that impact people's lives. A lot

- Charlotte, NC
new job!

This position will have oversight of Quality Systems implementation and management; audit support; Quality Assurance and Quality Control operations; and compliance for the Fiber Business Group in accordance with established practices, processes, regulations, guidelines and standards in a safe and efficient manner. Essential Duties and Responsibilities: Take leadership and ownership of Quality, ensuring product design Quality relative to manufacturing and product safety, and regulatory....

- Sturgis, MI
new job!

A manufacturer of plastic injected molded medical and aviation components is seeking a Process Engineer for their operation. This facility is located in southwest Michigan and close to South Bend and Elkhart Indiana and Kalamazoo and Portage Michigan. Basic Role This position, reporting to the Engineering Manager, will oversee the technical/manufacturing aspects of the molding department, develop robust manufacturing processes for medical device, aviation components and other commercial parts,

- East Hanover, NJ

To be considered for this position you must have at least 7 or more years of regulatory affairs experience in the area of In Vitro Diagnostics (IVD) along with hands-on preparation of 510K submissions for IVD products. Strongly prefer someone form the medical device industry (not pharmaceutical mfg). Any experience dealing with face-2-face meetings with regulators (like Pre-Submission meetings) will be considered a valuable asset. Provide regulatory strategies for products, including....

- Pittsburgh, PA

My client’s team is growing and they look to add a new Scientist to their team. The ideal candidate will solve technically challenging problems, develop new and improved products and services, and liaise with a team of technical professionals focused on patient health. The ideal candidate will take on the following tasks:Create algorithms to advance the company strategy of improving outcomes for at-risk patients.Collaborate with physicians, software engineers, and data scientists to identify....

- Pierceton, IN

Prepare and maintain multi-axis mill, wire EDM, laser and lathe programs for CNC Machine Tools Develop manufacturing processes for new products, and other in-house applications; i.e. gauges, tools and fixtures Design or help in the design of jigs, tools, fixtures, and special equipment for CNC applications Identify excessive cost, develop methods for cost reductions, and implement identified cost reductions Assist quality engineers and operators with the validation of new or revised programs....


Channel Sales Director - Global role Our client, a $100M division of a $500M company serving the medical device and life science sectors is currently expanding and creating a new Director of Channel Sales role! The Director of Channel Sales is responsible for the development, expansion, and management of new and existing strategic partners worldwide. The primary focus area of this individual will be the design, development and rollout of a channel distribution model for the full division....


Channel Sales Director - Global role Our client, a $100M division of a $500M company serving the medical device and life science sectors is currently expanding and creating a new Director of Channel Sales role! The Director of Channel Sales is responsible for the development, expansion, and management of new and existing strategic partners worldwide. The primary focus area of this individual will be the design, development and rollout of a channel distribution model for the full division....


Channel Sales Director - Global role Our client, a $100M division of a $500M company serving the medical device and life science sectors is currently expanding and creating a new Director of Channel Sales role! The Director of Channel Sales is responsible for the development, expansion, and management of new and existing strategic partners worldwide. The primary focus area of this individual will be the design, development and rollout of a channel distribution model for the full division....


Channel Sales Director - Global role Our client, a $100M division (on track to double sales by next year) of a $500M company serving the medical device and life science sectors is currently expanding and creating a new Director of Channel Sales role! The Director of Channel Sales is responsible for the development, expansion, and management of new and existing strategic partners worldwide. The primary focus area of this individual will be the design, development and rollout of a channel....


Site Director of Quality - Medical Device Operations The Global leader in the development and production of surgical medical devices seeks a Site Director of Quality to lead all quality activities at one of the company's manufacturing sites in New England USA. The Quality Director will lead a quality group of more than 30 indirect reports with three direct reports. This site has approximately 450 non-union full time employees. The Site Director of quality reports to the VP of Quality for this....

- Bedford, MA

Applications Engineer Our client, a $100M division of a $500M company serving the medical device and life science sectors is currently expanding and hiring an Application Engineer! The Applications Engineer will participate in a group that has a very direct impact on the company's future revenue and growth strategy. Through the pre-sale process, the Applications Engineering group gathers customer requirements, determines the most creative value added solution and ultimately estimates the....

- Knoxville, TN

FDA-Regulated manufacturing facility in E.TN has immediate need for a QA Manager with experience in medical device or pharmaceutical manufacturing. The QA Manager will be the Quality expert for the plant and will serve as a key member of the plant leadership team. The QA Manager will be responsible for validating new and existing equipment in addition to developing the product safety plan. The QA Manager will report to the Plant Manager and will direct a Lab Manager, Lab Techs, Plant QA Techs,


Senior Manager of Strategic Upstream Marketing Our client, a $100M division of a $500M company serving the medical device and life science sectors is currently expanding and creating a new Senior Manager of Strategic Upstream Marketing role! The Senior Manager of Strategic Upstream Marketing is responsible for the building a robust detection and analysis (D&A) portfolio strategy for the division. The individual will create the umbrella strategy and define the roles of key technologies....

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