Process Engineer II

Company: GENIUS TALENT
Location: Charlotte
Posted on: November 26, 2022

Job Description:

Genius Talent has partnered up with a growing leading global healthcare organization who has an immediate need for a full time Process Engineer II in Charlotte, NC. This full time Process Engineer II is responsible for developing, sustaining, and validating processes and equipment used in the manufacture of medical device product(s) including determination of process flow, fixture/tooling development, and generation of engineering and production documentation. This includes work instructions and process FMEAs for both internal and supplier-based processes. Essential Job Functions Work with production facilities and vendors to develop, evaluate, document, implement and improve manufacturing processes throughout the product life cycle, including process control techniques, related fixtures, and tooling,training personnel when required, and estimation of staffing requirements, production times, and relative costs to provide data for production decisions Support cross-functional projects related to existing and new products, as necessary, including recommended changes to specifications based on manufacturing process input. Comply with all SOP and regulatory requirements pertaining to the development of medical device (per FDA 21 CFR part 820 and ISO 13485) Execute on production transfers, including production floor layout and facility planning activities (equipment spacing, utilities, etc.) Plan, create, and execute validations (IQ/OQ/PQ) in accordance with FDA and ISO harmonized standards including preparation of technical protocols, reports, and feasibility studies Create and maintain accurate documentation of process specifications, work instructions, tooling drawings, design concepts, shop orders, and concepts in accordance with the R&D and quality assurance functions Provide engineering support for production facilities, including vendors, to trouble shoot and resolve technical problems Required Qualifications B.S. degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Packaging Science, or other appropriate engineering discipline Minimum of 3 years of relevant experience in the medical device and/or pharmaceutical field, with a demonstrated understanding of industry requirements and regulations Excellent problem-solving skills, including experience implementing the DMAIC thought process and structured root cause analysis Preferred Qualifications Experience with process mapping, development, characterization, qualification/validation, and capability analysis preferred Experience in 3D modeling and drafting; Solid Works or Solid Edge software experience preferredJob Type: Full-timeBenefits: 401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insuranceExperience level: 3 yearsSchedule: 8 hour shift Day shift Monday to FridayWork setting: In-personAbility to commute/relocate: Charlotte, NC 28269: Reliably commute or planning to relocate before starting work (Required)Work Location: One location

Keywords: GENIUS TALENT, Charlotte , Process Engineer II, Engineering , Charlotte, North Carolina