- Merck & Co. (Rahway, NJ)
- …and reports, conducting system hazard analyses and Failure Modes and Effects Analysis (FMEA), implementing risk control measures, and performing overall device ... Job DescriptionThe Senior Scientist, Device Risk Management Lead, is a crucial member of...a crucial member of our team, responsible for spearheading risk management efforts in combination product development, commercialization, and… more
- Syner-G BioPharma Group (Boston, MA)
- …medical device industry.Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required.Validation expertise in Equipment, CSV, Method, and ... commissioning and qualification of facilities, utilities, and equipment (FUE).Assist with risk assessments, feasibility reviews, risk mitigations, and testing of… more
- Comau LLC (Southfield, MI)
- …projects core responsibility for support Project Team and Site on the lines risk analysis assessment. Duties and Responsibilities Main areas of responsibilities ... the use of company standards (product, processes, norms ) Develops the risk analysis activity for tooling, robotic cells and automated systems, in order to… more
- Genmab (NJ)
- …assessments, country and site selection, patient recruitment forecasting, and operational risk analysis .Serve as a senior strategic partner to Development ... Operations (DevOps), Clinical Strategy and external partners to inform study design and operational delivery strategies.Shape feasibility approaches and standards by incorporating internal and external data sources, novel technologies, and evolving regulatory… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …standards and policies and business objectives Presents clear position statement and risk analysis to leaders in the regulatory department, medical affairs ... and other departments as needed Serve as the Promotional Regulatory Affairs lead for a new product launch through contributions to the US Core launch team for assigned product in oncology. Provide regulatory advice, and support to the organization. Lead the… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Quality and the CMO teams to collaboratively drive the deliverables and timelines.Conduct risk and gap analysis , maintain risk registry and develop ... mitigation strategies.Provide timely and accurate update on the CMO Business performance to the manager and cross functional stakeholders.Support escalations, business planning and contract negotiation in a timely manner. RequirementsBS/MS is required in… more
- Merck & Co. (Rahway, NJ)
- …Packaging Engineering, Process Optimization, Product Packaging Design, Project Leadership, Risk Management, Root Cause Analysis (RCA), Technical Leadership, ... with application of Lean Six Sigma principles, as well as Risk Management tools.Understanding of new product introduction, commercial supply, lifecycle… more
- Aptyx (Charlotte, NC)
- …supplier engagement, raw material qualification, and specification development. Participate in risk management activities including design failure mode analysis ... process issues through structured problem solving and data driven analysis . Required Qualifications Bachelor's degree in biomedical engineering, mechanical… more
- Stellantis (Auburn Hills, MI)
- …restrictions, and process-related problems. Lead DFMEA (Design Failure Mode and Effects Analysis ) and other risk assessment activities to ensure design ... reliability, and performance requirements. Support CAD modeling, FEA (Finite Element Analysis ), and other design validation methods to ensure structural integrity… more
- Stellantis (Auburn Hills, MI)
- …challenges, and process-related problems. Lead DFMEA (Design Failure Mode and Effects Analysis ) and other risk assessment activities to ensure design robustness ... and quality, durability, NVH, etc. Support CAD modeling, FEA (Finite Element Analysis ), and other design validation methods to ensure structural integrity and… more
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