Senior Design Quality Engineer

ICDS Recruitment

Westmeath

Senior Design Quality Engineer - County Westmeath. This position is one of development, improvement and innovation. In this role you will be tasked to provide quality engineering support in design and development of medical device products. Facilitate the application of design controls in product development and sustaining changes. Provide support in the rapid resolution of product complaints and/or safety issues. As Senior Design Quality engineer, your key accountabilities will involve: • Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements. • Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations. • Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, dFMEA, and risk management report. • Assist in the creation of verification and validation test plans, protocols and reports. Oversee testing and analysis for standards and product requirements compliance. • Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques. Skills & Qualifications Required: • BSc Mechanical engineering or related discipline with at least 5 years’ experience in a similar role. • Good verbal and written communication skills including protocol / report development and technical presentations. • Experience of Risk Management ISO 14971. • Experience of Process Validation (IQ, OQ, PQ), DOE, SPC and capability analysis. • Experience of verification/validation test plan development and root cause failure analysis. Preferred requirements: • Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive. Desirable: • Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis. • Familiar with statistical software tools (Minitab, Stat Graphics, Statistical. • Stability, Biocompatibility, Sterilization, Ship Testing Knowledge. Other Skills: • Computer literate and experience with PCs, networks, and applications. • DFSS / Lean Green Belt or Black Belt (Desirable. • Familiar with DMAIC or DMADV(DFSS) methodologies (Desirable. • Familiar with IEC 60601, ISO 5361, ISO 5366 and product specific industry standards (Desirable. Notes: Travel will be required as part of the job with an estimate of 5-10% travel requirements. This job originally appeared on RecruitIreland.com.

2590 days ago