- Merck & Co. (Rahway, NJ)
- …activities with the clinical, regulatory, formulation, commercial and other key company functions. Lead the Device Engineering Sub-Teams focused on ... launch. The ideal candidate will possess extensive knowledge in medical device engineering , particularly in the design, manufacturing, verification, validation… more
- Merck & Co. (Rahway, NJ)
- …regulatory, company, and customer requirements.- -Principal ResponsibilitiesLead/contribute to device development, design controls for the assigned projects. Lead ... - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) Team designs, develops, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards. The Lead is responsible for defining and ... around rare diseases and immune disorders. SummaryThe Regulated Implementation Services Lead plays a key role in overseeing the development, validation,… more
- Merck & Co. (Rahway, NJ)
- …proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.Qualifications:Bachelor's degree in Mechanical Engineering , Biomedical ... syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to...PhD) preferred.Minimum of 10 years of experience in medical device or combination product engineering , with at… more
- Merck & Co. (Rahway, NJ)
- …control strategies, statistical analysis, and advanced statistical methods for medical device and combination product engineering within the pharmaceutical ... device and combination product regulations, manufacturing processes, and quality control.Proficiency in advanced statistical methods, such as partial least… more
- Merck & Co. (Rahway, NJ)
- …Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team whose roles include design and ... (PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable patient centric products for patients. The successful… more
- Merck & Co. (Durham, NC)
- …experience in Biopharmaceutical industry across multiple manufacturing disciplines (Operations, Quality , Technology, Engineering , Supply Chain, etc.).-At least ... Mindset - Demonstrated ability to deliver compliant supply and achieve highest quality , lowest cost, and shortest lead -time. Strategic Thinking - Ability… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Digital Device Quality Engineering Lead **Location** : Cambridge, MA **About the Job** At Sanofi, we're committed to providing the ... care journey, with external LMR partnerships. Join our Global Digital Team as a Digital Device Quality Engineering Lead . You will be responsible for the … more
- Merck (Rahway, NJ)
- …with the clinical, regulatory, formulation, commercial and other key company functions. + Lead the Device Engineering Sub-Teams focused on development of ... launch. The ideal candidate will possess extensive knowledge in medical device engineering , particularly in the design, manufacturing, verification, validation… more
- Gilead Sciences, Inc. (Foster City, CA)
- …possible, together. **Job Description** We are seeking a dynamic and people-focused Director of Device Development to lead a team of engineers in the design and ... and managing device engineers. + A Bachelor's Degree in Mechanical Engineering , Chemical Engineering , Biomedical Engineering , or a related scientific… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** GRA Device Lead (Director) **Location** : Morristown, NJ, Cambridge, MA, Framingham, MA **About the Job** Are you ready to shape the future of ... regulatory affairs (GRA) function is comprised of more than 1800 people. The GRA Device Lead for Specialty Care Combination Products will oversee key regulatory… more
- Global Foundries (Essex Junction, VT)
- …visit www.gf.com. Summary of Role: This position is for an experienced RF Device Compact Modeling Engineer. The candidate will be responsible for transistor models ... responsibilities will include modeling interface role to Fab and technology device teams, compact model correlation to hardware, targeting, benchmarking, test… more
- Lilly (Indianapolis, IN)
- …& QC Operations (AQCO) team, your role as the Global QC Operations - Parenteral and Device Network Lead is to work in conjunction with the QC Laboratories across ... and you'll partner with your peers in ACQO that lead these workstreams to deliver on the project plans....line relationship to the Senior Vice Presidents of Global Quality for the Parenteral and Device Networks.… more
- Amazon (Monroe, OH)
- Description The Device Quality Manager (DQM) is responsible for ensuring that Amazon products are produced and packaged to meet or exceed our high bar for ... excellent customer experience. The DQM is responsible for the device quality during development of each project,...by monitoring and reporting on production performance against established quality goals; * lead development and updates… more
- Edwards Lifesciences (Naperville, IL)
- …expertise in the optimization of manufacturing processes. Key Responsibilities: + Lead and direct electrical engineering and software development projects ... reliability, accuracy and throughput of product. + Address key bottleneck/ quality related manufacturing processes and develop/document/implement projects to eliminate… more
- Kelly Services (Springfield, MO)
- **Overview:** Our client is seeking a Contract Quality Engineer with medical device experience to support the successful implementation of ISO 13485 at our ... work instructions, procedures, and records. + Collaborate with cross-functional teams ( Quality , Operations, Engineering ) to ensure compliance and understanding.… more
- Bausch Health (Bothell, WA)
- …progress and impact. The Senior Manager will report to the VP of R&D and lead and manage a team of engineers, designers, and technicians to research, plan, and ... with other departments to ensure projects conform to all regulatory and quality regulations. Prototype designs using a variety of prototyping methodologies including… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …(Design Engineering , Human Factors, V&V Engineering , Manufacturing Engineer, Quality Engineering ) through the complete device design and development ... Device Development Engineer to join our project lead team. This is a non-lab based position. They...partners/CDMOs. + Leads all aspects of product testing and quality assurance processes for the specific device … more
- Kelly Services (Germantown, WI)
- …technical field is preferred. + 2-3 years of experience in a quality engineering role within the medical device manufacturing environment + Understanding of ... Engineering client has asked us to find a ** Quality Engineer** to join their team to help develop...customer change notices. + Serve as manufacturing liaison for quality -related issues. + Approve medical device releases:… more
- Takeda Pharmaceuticals (Lexington, MA)
- …+ Coordinate risk mitigation activities across clinical, regulatory, quality , and engineering functions + Perform safety reviews on device and combination ... clinical liaison to Global Device Team, including engineering , regulatory affairs, quality , and commercial functions...and quality standards, and patient-focused innovation. + Lead , mentor, and develop organization on device … more
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