Associate Design Engineer

Zeus is a leading polymer extrusion manufacturer and material science innovator. They are seeking an Associate Design Engineer to join their engineering team, responsible for establishing design verification protocols, supporting process validation, and promoting compliance with quality standards in the development of medical products.ResponsibilitiesEstablish design verification protocols and reports with input from the project manager and manufacturing engineering. Perform independent verification of test data and analyze resultsDraft or provide input on test methods, test method validation, and general testing requirements to ensure that standards, regulations and guidance document criteria are metSupport process validation and technology transfer studies for special processes to improve CathX Medical quality assurance methodologyDevelop master validation plans and reports based on input from customers’ and project teamsReview and provide input on calibration, preventive maintenance, IQ/OQ, PQ and software validation protocols for inspection, measuring, manufacturing, and testing equipmentSupport all aspects of risk management including hazard analysis, Design FMEA and Process FMEA for DV and TX projectsObtain and gain agreement on any special quality, test, and certification requirements in cooperation with the project team and assure overall agreement between CathX Medical and customer drawings and specifications for DV and TX projectsDraft and execute design of experiments (DOE) and capability studies with the input and support of the manufacturing engineer and project managerWork as a part of a core team with R&D, Project manager, Manufacturing engineering and business development as required in new product introduction for DV and TX projectsPerform statistical analysis of test data and inspection results for new product introductionPromote a culture of compliance to company proceduresSkillsOne or more years' experience in quality engineering and project engineeringBS degree in science, engineering, or manufacturing or equivalent experience or certificationsDemonstrated expertise in quality concepts, practices, and proceduresAbility to work collaboratively with customersStrong interpersonal skills are requiredAbility to plan, establish and coordinate test and inspection procedures, conduct process capability studies, test method validations, prepare statistical quality control data and develop statistical designed experimentsKnowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971Ability to travel as necessaryBenefitsCompetitive payGreat benefits packageCompany OverviewDelivering dependable and innovative polymer solutions for over 50 years. It was founded in 1966, and is headquartered in Orangeburg, South Carolina, USA, with a workforce of 1001-5000 employees. Its website is http://www.zeusinc.com.Company H1B SponsorshipZeus has a track record of offering H1B sponsorships, with 1 in 2023, 1 in 2022. Please note that this does not guarantee sponsorship for this specific role.



Apply To This Job