- 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
- 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)
- …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
- 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
- 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
- Aequor (Fort Worth, TX)
- …you are responsible for handling facilities, equipment, and personnel to manufacture medical device products, following established standards and procedures (eg, ... cGMP and SOPs), driving growth, and optimizing and improving the manufacturing process at our Manufacturing Facility in Fort Worth North, TX. This role will support… more
- Merck & Co. (Rahway, NJ)
- …Engineering Standards, Key Performance Indicators (KPI), Leading International Teams, Management Process , Manufacturing Scale-Up, Medical Device Regulations, ... fields Required Skills and Experience: Subject matter expertise in packaging and/or medical device and combination product components as well as development… more
- Twist BioScience (South San Francisco, CA)
- …Regulatory Affairs, Supplier Quality, Supply Chain, Quality Control, Production, Process Development, Product Development, Software Development, R&D, Global Support ... occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design,… more
- Oracle (Trenton, NJ)
- …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
- 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 (Salt Lake City, UT)
- …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
- Merck & Co. (Rahway, NJ)
- …transportation technologies for pharmaceutical products including parenteral and/or medical device and combination products.Demonstrated experience in ... culture of continuous improvement.-Deliver the development, design, construction, qualification/ validation and/or initial operation of complex tertiary packaging components… more
- Merck & Co. (Rahway, NJ)
- …transportation technologies for pharmaceutical products including parenteral and/or medical device and combination products. Demonstrated experience ... across the network. Deliver the development, design, construction, qualification/ validation and/or initial operation of complex tertiary packaging components and… 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
- Teleflex (Maple Grove, MN)
- …- Train and direct technicians in performing equipment qualifications, process characterization, test method validation execution, failure investigations. ... characterization to allow selection of optimal design concepts and process technology. - Design the structure of flows of...Advanced knowledge and experience with IQ, OQ, and PQ validation , DV and TMV testing of medical … more
- Battelle Memorial Institute (Columbus, OH)
- …(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
- GRAIL (Durham, NC)
- …management system (QMS). This role's focus is on the in vitro diagnostic medical device processes, supporting the clinical laboratory processes as needed with ... regular on-site presence (5 days a week) **Responsibilities:** + Support medical device Quality Engineering operations through expert interpretation,… more
