- Merck & Co. (Rahway, NJ)
- …cross-functional impact, including drug device /combination products and software as medical device platforms.- Reviews and resolves issues that span diverse ... (Research & Development) by:Developing an active engagement strategy with US FDA and global health authorities to advocate advanced regulatory strategies for… more
- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward ... (PSCS) deliverable which is the development of robust compositions, processes and device / packaging that enable patient centric products for patients. The successful… more
- AbbVie (Pleasanton, CA)
- … FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... our talent pipeline and considered for future opportunities. The Device Engineer will work collaboratively with a team to...work collaboratively with a team to design and develop medical products from initial concept through the transfer to… more
- RESILIENCE (West Chester, OH)
- …and Kaizen events, manual data collection) to achieve a prescribed level of purity, quality , and consistency in product and work output in accordance with cGMPs. Job ... move, store or deliver material to the proper location. *Perform visual quality inspection and sampling of in-process materials. Promptly escalate concerns to Lead… more
- MicroVention (Aliso Viejo, CA)
- …field. Minimum six (6) years of direct clinical research experience, preferably in the medical device industry, including at least two (2) years of monitoring ... in various therapeutic areas (preferred areas: Neurovascular and/or Cardiovascular). Experience in the medical device industry. At least two (2) years of project… more
- Axogen (Vandalia, OH)
- …with ANSI/ASQ Z1.4-2003, c=0 and AQL methodologies preferred Experience in an FDA -regulated environment, particularly medical device , human tissue or ... School Diploma and minimum of 0-2 years of relevant industry experience within a Medical Device , Pharmaceutical, or Tissue commercial organization. Familiarity… more
- Zenflow (South San Francisco, CA)
- About Zenflow Zenflow, Inc. is a privately held medical device company dedicated to improving treatment for patients suffering from urinary obstruction caused by ... and is not approved for commercial sale. POSITION OVERVIEW: We are a dynamic medical device start-up seeking a highly skilled and motivated Senior Manufacturing… more
- Natus Medical (Middleton, WI)
- …other test software language/platform Knowledge of regulatory requirements in medical device industry Experience in FDA Quality System Regulations, ... / Design for Test guidance. Deliver medical device design documentation compliant with FDA design...Current Good Manufacturing Practices, risk management (ISO 14971], and Quality Management Systems for Medical Devices [ISO… more
- Carolina Precision Technologies (Warminster, PA)
- …Minimum Requirements: High School diploma or GED preferred 3-5 years experience in medical device manufacturing or related field Familiarity with ISO 13485, and ... (CPT) is a premier, full-service precision manufacturer for the medical and aerospace industries. We are a market leading...MedSurg applications. We are currently seeking a full time Quality Control Supervisor at our facility in Warminster, PA.… more
- Hyperfine (Guilford, CT)
- …experience in Engineering or Quality role. 3 years of experience in team-based medical device product development. Knowledge of all aspects of medical ... that has redefined brain imaging with the Swoop(R) system-the first FDA -cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of… more
- Agiliti Health, Inc. (Milwaukee, WI)
- … device ISO14971 Risk Management. *Previous working experience in a Design Quality Assurance role for medical device equipment is required. *Working ... The Quality Engineer II will utilize and maintain ...with manufacturing and engineering teams. *Leads activities to support medical device manufacturing, such as Risk Management,… more
- Smith & Nephew (Pittsburgh, PA)
- …in Regulatory Affairs Experience with a Class II devices Knowledge and practical application of medical device regulations (ISO, GMP, FDA , CE, EU MDR) and ... this role, you will lead and support global regulatory submissions for new and modified medical devices, including those for the US and EU markets. You act as the… more
- LanceSoft (Boulder, CO)
- …barrier systems, sterile barrier systems and packaging systems. 3. Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & ... and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1...packaging or process and process Risk Management as per FDA & ISO standards. 6. Six Sigma/ Design for… more
- CVS Health (Malvern, PA)
- …to providing our Pharmacists with the resources needed to deliver the highest quality patient care. As a Pharmacist for our Specialty Compounding Pharmacy, you will ... orders. 4. Participates in patient evaluation for acceptance, product selection, device selection, and supply management, working with admission team and nursing… more
- Johnson and Johnson (Danvers, MA)
- …or a related field. 10+ years of experience in process validation within the medical device industry , with a focus on electro-mechanical systems. Demonstrated ... Validation Engineer to lead process validation initiatives for complex electro-mechanical medical devices. This senior-level role is critical to ensuring product … more
- Biomerics (Minneapolis, MN)
- …is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, ... role is responsible for supporting the development, validation, and production readiness of medical device tubing processes. The ideal candidate will have deep… more
- Life Science Logistics (Memphis, TN)
- …years' experience in warehousing or 3PL environment Minimum of 3 - 5 years in Quality in the medical device and/or pharmaceutical or other regulated industry ... Interact with state and federal agencies, clients, and corporate quality group Work with Quality Systems, policies...per 21 CFR 210/211 and 820 Verifiable aptitude of FDA and DEA regulations Certified auditor training per ASQ… more
- Medtronic (Northridge, CA)
- …experience with 5+ years of managerial experience Nice to have Experience in medical device , pharmaceutical, or life sciences industries is strongly preferred. ... for identifying value-creating opportunities, managing sourcing events, and driving cost, quality , and service excellence across a global portfolio of BPO suppliers.… more
- Edwards Lifesciences Corporation (Dallas, TX)
- …We are rewriting the playbook on heart failure treatment. We're not just a medical device company; we're trailblazers on a mission to redefine healthcare. Our ... Sensor is revolutionizing how heart failure is managed, improving quality of life while slashing hospital admissions and health...5 years experience of progressive sales experience in the medical device industry Experience in cardiac or… more
- Katalyst HealthCares and Life Sciences (Alviso, CA)
- …editing/redlining of old test methods. Experience working in a regulated and/or medical device environment. To define equipment requirements. To draft equipment ... related to equipment Working. Requirements: 3 years of relevant experience in medical device manufacturing. Clean room environment experience. Experience with… more
