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Prior experience in medical device or pharmaceutical manufacturing is preferred. Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired. As a Quality Engineer you will ensure compliance to company/divisional policies and procedures and with FDA and ISO requirements by reviewing non-conformances, complaints, defect reports, and audit findings in order to coordinate corrective action.
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Background in SPICE simulation, SOA, device operating conditions, and knowledge of Post-layout extraction is a plus. Experience with custom Schematic/Layout tracing via SPICE/Open Access, power gating techniques, biasing, circuit topologies (power switches, level-shifter, iso), virtual/derived/multi-power domains, standard-cells would be helpful.
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Coordinate with team members to efficiently process Change requests according to ISO, quality and/or change management standards. Experience in a regulated industry is preferred; ideally med device, pharma or biotech.
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Work independently and as a team member to plan, write, and execute test cases according to client practices, FDA regulatory, and ISO standard procedures. Bachelor's degree in Computer Science, Computer, Electrical or Biomedical Engineering/Degree in computer science, EE, or Biomedical required - New Grad okay with med device internship experience, master's degree okay.
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Must have familiarity with Good Manufacturing Practices (GMP) Preferred: Familiarity with ISO, IEC, and other standards pertaining to the medical device industry. Must have the ability to read and interpret technical drawings, schematics, and documentation related to medical device manufacturing Preferred: Proficiency in CAD software (Fusion 360) and GD&T.
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Responsibilities include: Work independently and as a team member to plan, write, and execute test cases according to company practices, FDA regulatory, and ISO standard procedures. Degree in computer science, EE, or Biomedical required - New Grad okay with med device internship experience, masters degree okay.
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Fasikl has obtained two simultaneous FDA Breakthrough Device Designations for its implantable systems, with MindForceTM Nerve-Computer Interface (NCI) admitted into FDA’s Total Product Life Cycle Advisory Program (TAP.
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This position is responsible for managing the Bedford Site’s Validation program that includes start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, and medical device/drug product manufacturing processes according to current Good Manufacturing Practices (cGMP), ISO requirements, and ICH guidelines.
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Our client is a manufacturer of electronic components serving both the aerospace and medical device industry. Experience in Medical Device, Aerospace, or Automotive industries. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
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Experience in designing and generating clinical documentation required per EU Medical Device Regulation, including authoring Clinical Evaluation Plans and Reports, Post Market Clinical Follow-up and driving clinical input to Post Market Surveillance Plans and Reports.
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Applies appropriate standards, processes, policies, procedures, and tools throughout the product/system development lifecycle, including Standard Operating Procedures (SOP’s) and applicable medical device development protocols under FDA Quality Systems Regulations, CE Marking, and ISO Quality Systems.
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Iuvo BioScience is a Premier Partner Research Organization serving the Medical Device, Pharmaceutical, and Ophthalmic Industries. Knowledge of cGMP/ISO/PDA/ICH/ISPE and strong documentation practices required.
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Develop innovative medical device solutions that meet industry standards and regulations such as FDA, IEC, and ISO. Knowledge of industry regulations and standards, such as FDA, IEC, and ISO.
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You should have knowledge of regulatory requirements that may affect a design such as ISO, UL, and IEC. Experience in medical device development specifically is a strong plus. As a Senior Systems Engineer -Technical Lead you will serve as the technical lead on our most complex new product development projects.
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Lead the software development for medical device product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDR requirements. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
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