Engineer II, Process Development
ITech Consulting Partners - Enfield, CT
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u003cdivu003eu003cpu003eThe Engineer II, Process Development will be responsible for designing, developing, and qualifying manufacturing processes for medical devices, leveraging expertise across multiple engineering disciplines. The role encompasses involvement in all stages of product development, including design, prototyping, documentation, validation, and manufacturing transfer. The Engineer II will focus on developing processes for new products, improving existing processes, and ensuring compliance with medical device quality regulations. This is an on-site position.u003c/pu003eu003chru003eu003cpu003eu003cstrongu003eKey Responsibilities:u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eu003cpu003eu003cstrongu003eProject Leadership u0026Communication:u003c/strongu003eu003cbru003eAttend and coordinate project meetings, serving as the primary contact for customers on low to moderate complexity projects, and as a secondary contact for more complex projects.u003cbru003eTrack project status, timelines, and budgets while ensuring timely communication of updates and resolution of questions.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eProposal u0026Quotation Support:u003c/strongu003eu003cbru003eAssist in the preparation of proposals and quotations, working closely with clients to clarify technical requirements and ensure accurate documentation.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eProject Planning u0026Execution:u003c/strongu003eu003cbru003eContribute to the creation and maintenance of project plans, ensuring alignment with key milestones, deadlines, and budgets. Collaborate with program management to track and communicate project status, issues, and action items.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eProcess Development:u003c/strongu003eu003cbru003eLead process-related initiatives including feasibility builds, equipment selection and qualification, process documentation, device verification testing, operator training, clinical builds, and process validation.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eDesign u0026Validation:u003c/strongu003eu003cbru003eEngage in full product lifecycle activities, including product design, material sourcing, prototyping, design verification and validation, and regulatory submission support. Assist in the transfer of products to manufacturing and provide ongoing support for existing product lines.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eQuality Assurance:u003c/strongu003eu003cbru003eEnsure compliance with medical device quality regulations throughout development and process transfer phases. Conduct root cause analysis and testing to resolve process-related issues.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eOperator Training u0026Documentation:u003c/strongu003eu003cbru003eTrain operators on new processes and ensure that all process documentation is accurate and up-to-date.u003cbru003eContribute to Process Failure Mode Effects Analysis (PFMEA) and other risk assessments.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eReliability u0026Compliance:u003c/strongu003eu003cbru003eDemonstrate consistent, reliable, and punctual attendance. Comply with company policies, quality, and safety standards.u003c/pu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eOther Duties:u003c/strongu003eu003cbru003ePerform other duties as required based on the needs of the business.u003c/pu003eu003c/liu003eu003c/ulu003eu003chru003eu003cpu003eu003cstrongu003eQualifications:u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eu003cpu003eu003cstrongu003eEducation u0026Experience:u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eBachelor's degree in a STEM engineering discipline (preferred)u003c/liu003eu003cliu003eMinimum of 2 years of relevant engineering experience, preferably in the medical device industryu003c/liu003eu003cliu003eExperience with mechanical, tool design, and manufacturing processesu003c/liu003eu003c/ulu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eTechnical Skills:u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eProficiency in MS Office, including Word, Excel, and PowerPointu003c/liu003eu003cliu003eExperience with Minitab and statistical analysisu003c/liu003eu003cliu003eStrong ability to interpret technical drawings, blueprints, and specificationsu003c/liu003eu003cliu003eFamiliarity with documented change control processes and technical reportingu003c/liu003eu003c/ulu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eCommunication u0026Organizational Skills:u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eExcellent verbal and written communication skills in Englishu003c/liu003eu003cliu003eStrong organizational skills, with attention to detail and ability to manage multiple tasksu003c/liu003eu003cliu003eAbility to prepare technical reports and deliver formal presentationsu003c/liu003eu003c/ulu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eAnalytical Skills u0026Problem-Solving:u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eStrong analytical skills, with the ability to gather and evaluate secondary research informationu003c/liu003eu003cliu003eAbility to apply new technologies and problem-solving techniques to engineering challengesu003c/liu003eu003c/ulu003eu003c/liu003eu003cliu003eu003cpu003eu003cstrongu003eEthics u0026Standards:u003c/strongu003eu003c/pu003eu003culu003eu003cliu003eHigh ethical standards and commitment to quality and safetyu003c/liu003eu003cliu003eWillingness to travel if requiredu003c/liu003eu003c/ulu003eu003c/liu003eu003c/ulu003eu003c/divu003e ', 'location ': 'Enfield, CT ', 'remote ':null, 'jobtype ': 'directhire ', 'remoteoption ': 'notspecified ', 'featuredonjobboard ':false, 'ownedbyagency ':false, 'externalid ': 'CT43-2738269
Created: 2024-09-09