Job Description
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.
Responsibilities
- Establish design verification protocols and reports with input from the project manager and manufacturing engineering. Perform independent verification of test data and analyze results
- Draft or provide input on test methods, test method validation, and general testing requirements to ensure that standards, regulations and guidance document criteria are met
- Support process validation and technology transfer studies for special processes to improve CathX Medical quality assurance methodology
- Develop master validation plans and reports based on input from customers’ and project teams
- Review and provide input on calibration, preventive maintenance, IQ/OQ, PQ and software validation protocols for inspection, measuring, manufacturing, and testing equipment
- Support all aspects of risk management including hazard analysis, Design FMEA and Process FMEA for DV and TX projects
- Obtain 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 projects
- Draft and execute design of experiments (DOE) and capability studies with the input and support of the manufacturing engineer and project manager
- Work 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 projects
- Perform statistical analysis of test data and inspection results for new product introduction
- Promote a culture of compliance to company procedures
Skills
- One or more years' experience in quality engineering and project engineering
- BS degree in science, engineering, or manufacturing or equivalent experience or certifications
- Demonstrated expertise in quality concepts, practices, and procedures
- Ability to work collaboratively with customers
- Strong interpersonal skills are required
- Ability 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 experiments
- Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971
- Ability to travel as necessary
Benefits
- Competitive pay
- Great benefits package
Company Overview
Company H1B Sponsorship
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