- Merck & Co. (Rahway, NJ)
- …knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs ... design validation , and control strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP,… more
- Syner-G BioPharma Group (Boston, MA)
- …Experience: 4-7 years of experience within the biotech, pharmaceutical, or medical device industry.Knowledge and experience working with FDA cGMP, ... impact. For more information, visit www.Synergbiopharma.com (Syner-G is seeking both Process and Validation Engineering Candidates) PROCESS ENGINEER… more
- Merck & Co. (Rahway, NJ)
- …Certification Six Sigma Certification Experience with device design, process development, design verification, and design validation Required Skills: ... DescriptionJ ob description This position will be responsible for leading and implementing medical device and combination product design controls for both new… more
- Aptyx (Charlotte, NC)
- …- High School Diploma or equivalent experience 2-5 years inspection experience ( medical device experience preferred) Computer experience and proficiency required ... for inspection, including organization and cleaning of station Audit samples of in- process components, sub-assemblies, and final product to ensure they meet customer… more
- ValSource, Inc. (Durham, NC)
- …Qualification and Validation (CQV) experience in Pharmaceutical, Biotech, Medical Device or related GMP manufacturing environment preferred. Recent ... validation of manufacturing equipment. Experience with cleaning validation , process and utility systems validation...ValSource will include: Paid Time Off (PTO) and Holidays Medical / Dental / Vision Insurance - premiums 100%… more
- Aptyx (Charlotte, NC)
- …performs the function of design engineer for product development work on medical devices in the Development department in support of the department's objectives ... all applicable SOPs included in the Training Matrix Develop and engineer disposable medical devices from concept to production Hands-on products and process … more
- Oracle (Salt Lake City, UT)
- …long-term technology strategy. You will guide product teams in interpreting and applying medical device standards (including IEC 62304, IEC 82304, and FDA ... support the adoption of compliant SDLC processes and tooling. Deep understanding of medical device software regulations and standards along with a proven… more
- Merck (West Point, PA)
- …knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs ... knowledge in device design, requirement management, design verification, automation/ process development, design validation , and control strategy. Knowledge… more
- Oracle (Indianapolis, IN)
- …is standing up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product strategy, ... patient safety, usability, and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager ( Medical… more
- Oracle (Salem, OR)
- …is standing up a specialized clinical product management team focused on medical device -aligned products. This team bridges clinical practice, product strategy, ... patient safety, usability, and compliance across our next-generation EHR and AI-enabled medical device platforms. As a Clinical Product Manager ( Medical… more
- Takeda Pharmaceuticals (Lexington, MA)
- …design, implementation, and continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring compliance with ... the "Apply" button, I understand that my employment application process with Takeda will commence and that the information...products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units,… more
- AbbVie (Somerville, NJ)
- …including 4 major validation subjects (eg Computer, Equipment, Cleaning, Process , etc.) preferred A technical background in medical devices, pharmaceutical, ... Equipment Qualification (IOQ/PQ) Quality System Experience (Veeva, Trackwise, ComplianceWire) Medical Device or Pharmaceutical Experience Required. Preferred … more
- Kelly Services (Norcross, GA)
- …or related scientific field. Experience: Minimum 7 years of experience ( medical device industry preferred). Skills & Capabilities: Strong collaboration ... You will lead risk management activities, oversee design verification and validation efforts, and drive continuous improvement initiatives that enhance product… more
- Lilly (Pleasant Prairie, WI)
- …or computer science-related field preferred Minimum 5 years working in the pharmaceutical or medical device industry in QA roles Minimum 3 years of experience in ... Has previous facility or area start up experience Has previous qualification and validation experience ( process automation and/or IT systems) Has previous Six… more
- Battelle Memorial Institute (Columbus, OH)
- …SolidWorks (preferred) or Creo along with PDM or Windchill vaults Preferred Qualifications Medical device or consumer product design engineer experience Hands on ... OH. You will be a core team member in the design and development of medical and commercial products and systems. This role contributes to all phases of product… more
- Stryker (Mahwah, NJ)
- …experience Proven new product introduction experience in a regulated industry ( medical device preferred) Strong knowledge of DFM, process validation , and ... volume production. Drive Design for Manufacturability (DFM), risk assessments, and process validation (IQ/OQ/PQ). Implement and promote lean manufacturing and… more
- Merck (Rahway, NJ)
- …and supply, including components, process , and equipment, as well as qualification and validation , medical device design controls and device risk ... Reporting into the Director Packaging Platform Technical Leadership the Associate Director Medical Device and Combination Product (MDCP) Platform Packaging and… more
- Integra LifeSciences (Princeton, NJ)
- …data, monitoring, and maintaining the sterility assurance used in Tissue Technology medical device manufacturing. The candidate must have experience managing as ... well as interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of… more
- PCI Pharma Services (Rockford, IL)
- …be responsible for planning, developing, implementing and monitoring the equipment and process validation strategy for PCI's Advanced Drug Delivery business. The ... of experience in an FDA regulated industry with strong preference to medical device or combination products. Demonstrated proficiency with personal computers,… more
- Globus Medical, Inc. (Methuen, MA)
- …electrical engineering principles, ensuring robust hardware solutions and compliance with medical device standards while driving innovation in product ... design. Foster a culture of innovation, collaboration, accountability and compliance with medical device standards. Ensure timely delivery of milestones within… more
