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Contributes to refinement, translation, allocation to subsystems, and management of stakeholder requirements. Contributes to definition of system interfaces, evaluates systems and makes solution recommendations. Contributes to cross discipline feasibility and tradeoff studies. Contributes to subsystem level design and technical reviews. Contributes to defect management, r
Posted Today
s. The Individual Bachelor's degree in a scientific or related discipline; or equivalent combination of education and experience. RAC (Regulatory Affairs Certification) is a plus. Minimum 8+ years of experience in a regulated Medical Device Industry required; In Vitro Diagnostic or Biologics Industry experience preferred. Minimum 6+ years of experience developing and execu
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Investigates, troubleshoots and manages customer equipment and software complaints and inquiries in accordance with internal procedures and customers' requirements. Maintains technical self competence, knowledge of company procedures, and customer related skills. Works independently and as part of a team. Contributes to process improvements. The Individual Minimum High Sc
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This Operator2 position will be required to Operate manufacturing machinery in Slide Manufacturing Utilize inspection tools, including visual inspection, to assess product quality Adhere to all approved and documented processes Work closely with maintenance/engineering to minimize equipment downtime Work closely with other manufacturing support areas to coordinate activit
Posted 1 day ago
Ortho Clinical Diagnostics
- Waltham, MA / Bridgeport, CT / Providence, RI
Customer Retention Maximize customer retention rates by ensuring customer satisfaction, executing pre defined customer touch point/call plan, leading customer training (on site, as needed), anticipating and defending against competitive threats, and leveraging strategic selling framework Menu Expansion Proactively team with CEM & HSE to identify and close menu expansion o
Posted 1 day ago
Perform and understand detailed test methods and procedures to include serological evaluation of blood and blood products using traditional methods and Column Agglutination Technology (CAT). Perform in process testing as required by processes and procedures utilizing equipment/instrumentation, such as microscope, blood and blood screening analyzers, calibrated pipettes, c
Posted 1 day ago
We are seeking a qualified individual who has experience installing, operating, maintaining, repairing and modifying electromechanical equipment, preferably in the field. Troubleshoot technical problems and systems issues. Determine technical solution in accordance with product and customer specifications, and recommends actions to company or customer representatives for
Posted 1 day ago
Individual will run, maintain, and troubleshoot Vitros 350, FS 5,1, 4600, and 3400 analyzers. This position works in partnership with manufacturing Operations, Product Support, and other technical support groups to ensure Quality and customer expectations are met prior to final release of the product. The individual will execute Vitros testing following Test Designs and a
Posted 1 day ago
Execute manufacturing or manufacturing support processes according to standard operating procedures and current curriculum. Support schedule adjustments to meet production, material receipt and shipping requirements. Work with Supervisor to review departmental production schedules, work orders and related information to ensure materials are available for production. Maint
Posted 1 day ago
Working collaboratively with the US Sales Organization, the Contract Manager will provide quotes and develop agreements, revising as needed throughout the negotiation process. Amend and restructure existing agreements when required. Track the status of new offers to measure win rates and cycle times. Ensure that all contracts are structured in accordance with Company poli
Posted 1 day ago
Work with the Global Head of Medical & Clinical Affairs on driving Care Pathway Mapping, working with Scientific Advisors and attending Scientific Conferences, Evaluate Medical Literature, Engage Regional KOLs, supporting education of existing products, evaluate and proposing new product candidates. Work with R&D/Marketing/Product Development Leaders on defining key medic
Posted 4 days ago
Independently plans and executes clinical studies and leads cross functional teams responsible for the planning, execution, analysis, and reporting of assigned clinical performance studies. Applies expertise in clinical data review and statistical analysis. Reviews and approves clinical designs, protocols, and summary reports. Ensures that assigned Clinical Affairs staff
Posted 1 day ago
Supports the development or update of product Risk Management Plan to proactively assess product risks and mitigate potential harm/hazards Conducts and oversees literature search to monitor product performance and safety Helps the development of post market safety surveillance reports Assist the Medical Safety Officer to assess the patient impact and developing health haz
Posted 4 days ago
Makes hiring recommendations. Trains employees. EOE/AA Disability/Veteran #LI SC1
Posted 1 day ago
Provides subject matter expertise for IVD clinical strategy, clinical trial design, and operations to ensure studies and programs are delivered on time, within budget, and with a high quality outcome. Drives performance and delivers outcomes with external stakeholders (staffing agencies, regulatory authorities, etc.) Creates and maintains key clinical trial documents such
Posted 4 days ago
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