Sr Design Quality Engineer

Must Have 

·       Review new and modified product design documentation 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 FDA Quality System Regulations, EU MDR and inhouse Standards.

·       Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).

·       Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.

·       Assist in the creation of verification and validation plans, protocol 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.

·       Strong in software design and development, software verification and validation activities

·       Review Design History Files and Technical Files for conformance to applicable requirements.

·       Participate when appropriate in audits

·       Demonstrates mastery of software development and testing methodologies

·       Independently develops test strategies for new, pre-concept features in development.

·       Provides guidance to associate and level 1 quality engineers.

·       Assesses the compliance of the software development methodology to the approved process.

·       Participate and provide input to training on department / division procedures and policies

·       Facilitates hazard analysis and SFMEA sessions.  Updates the risk management file.

·       Acts as the subject matter expert on risk management for one or more products/platforms.

·       Ensures applicability to SOUP / OTS validations in the product development

·       Participates on CCB to decide upon CR implementation.

·       Applies quality system regulations, applicable standards and guidance to multiple projects

·       Develop templates and training based on the quality system regulations, applicable standards and guidance.

·       Independently reviews all SW deliverables to ensure compliance with development process and the standard.

·       Deliver presentations to the QA organization on status and issues of assigned projects.
Deliver training to departments outside of QA.

·       Demonstrates ability to effectively play multiple roles on a cross-functional team including contributor, subject matter expert, leader, facilitator.

·       Previous experience working in a cross-functional team environment.

·       Hands-on experience on Risk Management, Design Controls. 

·       Provide Quality support to facilitate resolution of product complaints and/or safety issues

·       Provide support to the Regulatory Department in writing technical submissions.

Minimum Qualification 

·       B E or B.Tech

·       Minimum 5-8 years of quality engineering experience or equivalence and overall 8-10 years of experience

 Key Technical Competencies 

·       Previous experience working in a cross-functional team environment.

·       Familiar with statistical software tools (Minitab, Stat Graphics)

·       Familiar with ISO 9001, ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.

·       Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.

·       Good verbal and written communication skills including protocol / report development andtechnical presentations.

·       Strong in software design and development, software verification and validation activities

·       Computer literate and experience with PCs, networks, applications, software development life cycle

·       Travel may be required

·       Knowledge in cybersecurity

 Nice to Haves 

·       ASQ CQE, CQA, CSQE and/or CRE certification.

·       ISO 9001 Internal Auditor / Lead Auditor Cerification

·       ISO 13485 Internal Auditor / Lead Auditor Cerification

·       Lean Six Sigma Green Belt or Black Belt

·       Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.

·       Familiar with DMAIC or DMADV(DFSS) methodologies

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About Medtronic

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