Senior Design Quality Engineer

3 weeks ago

Hyderabad Secunderabad Telangana India Medtronic Cardiac and Vascular Full time

Careers that Change Lives

Provide design quality engineering support in design and development of medical device products. Facilitate the application of design controls in product development and sustaining changes.

A Day in the Life

.Review new and modified product design documentation for quality characteristics,including manufacturability, serviceability, testability, reliability, and product requirements.

.Capable of mentoring junior quality engineers in providing quality engineering support for their medical device products.

MustHave

.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

Your Answer

Is this the position you were waiting for Then please apply directly via the apply button

  • Senior Facade Designer

    3 hours ago

    india CladUp Design Ltd Full time

    Company Description CladUp Design Ltd is a design engineering studio specializing in facade design. We have extensive experience in Rainscreen cladding, Precast facade, GRC panels, Window/Doors, and curtain walling industry. Our expertise lies in preparing accurate and reliable facade design solutions. We offer a range of services including concept...

  • Quality Assurance Quality Control Engineer

    5 days ago

    india QUALITY CONCEPT WELDING SOLUTIONS PRIVATE LIMITED Full time

    Company Description QUALITY CONCEPT WELDING SOLUTIONS PRIVATE LIMITED is a group of engineering services based in Noida. We provide innovative solutions for Training and Certification, Inspection and Testing, and Welding Consultancy. For more information, please visit our website: Role Description This is a full-time on-site role for a Quality Assurance...

  • Senior Quality Engineer

    5 days ago

    india Fanatics Full time

    Role Purpose: As a Senior Quality Engineer at Fanatics, you will specialize in creating test cases, building automated testing and pipelines for test suites, reporting capabilities and continuous integration to ensure the proper function of our fulfillment systems. You’ll be part of a multi-disciplinary Quality Engineering team while also working closely...

  • Senior Design Quality Engineer

    1 week ago

    hyderabad, India FICOSA Full time

    MISSION Assure the fulfilment of customer and Ficosa quality requirements at each development stage according to FDS / FRS procedure. GENERAL FUNCTIONS Ensure together with the Product Engineer and the Product Engineering Master the fulfilment of product quality requirements established with the Customer, in accordance with...

  • Senior Design Quality Engineer

    2 weeks ago

    Hyderabad, India FICOSA Full time

    MISSION Assure the fulfilment of customer and Ficosa quality requirements at each development stage according to FDS / FRS procedure. GENERAL FUNCTIONS Ensure together with the Product Engineer and the Product Engineering Master the fulfilment of product quality requirements established with the Customer, in accordance with Ficosa...

  • Design Quality Engineer

    1 week ago

    india QuEST Global Services Pte. Ltd Full time

    Quest Global is an organization at the forefront of innovation and one of the world’s fastest growing engineering services firms with deep domain knowledge and recognized expertise in the top OEMs across seven industries. We are a twenty-five-year-old company on a journey to becoming a centenary one, driven by aspiration, hunger and humility. We are...

  • Senior Traffic Engineer

    2 hours ago

    Secunderabad, India IBI Group Full time

    Senior Traffic EngineerFull-timeCompany DescriptionWe are a global architecture, engineering, planning, and technology firm defining the cities of tomorrow.By connecting design and technology, we change how people experience their built environment. We work across disciplines to create the intelligent systems, sustainable buildings, and efficient...

  • Senior Quality Engineer

    4 days ago

    Hyderabad, India Fanatics Full time

    Role Purpose:As a Senior Quality Engineer at Fanatics, you will specialize in creating test cases, building automatedtesting and pipelines for test suites, reporting capabilities and continuous integration to ensure theproper function of our fulfillment systems. You’ll be part of a multi-disciplinary Quality Engineering teamwhile also working closely with...

  • Senior Quality Engineer

    2 days ago

    Hyderabad, India Fanatics Full time

    Role Purpose:As a Senior Quality Engineer at Fanatics, you will specialize in creating test cases, building automatedtesting and pipelines for test suites, reporting capabilities and continuous integration to ensure theproper function of our fulfillment systems. You’ll be part of a multi-disciplinary Quality Engineering teamwhile also working closely with...

  • Senior Traffic Engineer

    1 week ago

    secunderabad, India IBI Group Full time

    Senior Traffic Engineer Full-time Company Description We are a global architecture, engineering, planning, and technology firm defining the cities of tomorrow. By connecting design and technology, we change how people experience their built environment. We work across disciplines to create the intelligent systems, sustainable...

  • Senior Traffic Engineer

    4 weeks ago

    Secunderabad, India IBI Group Full time

    Senior Traffic Engineer Full-time Company Description We are a global architecture, engineering, planning, and technology firm defining the cities of tomorrow. By connecting design and technology, we change how people experience their built environment. We work across disciplines to create the intelligent systems, sustainable buildings, and...

  • Senior Quality Engineer.

    2 hours ago

    Hyderabad, India Medtronic Full time

    Careers that Change LivesWe’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide. Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship,...

  • Senior Design Engineer

    1 week ago

    india Green Scout Full time

    Job Description ROLE: SENIOR DESIGN ENGINEERSALARY: £60000 to £70000LOCATION: NORTHAMPTONSHIRE, ESSEX, GLOUCESTERSHIRE, WORCESTERSHIRE, OXFORDSHIRE, THAMES VALLEY, BEDFORDSHIRE, LONDONOur client is recruiting for Senior Design Engineers  to join their growing design team in the UK.As a Senior Design Engineer you will be part of the Transmission Design...

  • Associate Electrical Engineer

    1 week ago

    india Hi-Quality Recruits Full time

    Job Description We are seeking an Associate Engineer to support a leading global mechanical and industrial engineering company in Washington D.C.  This is an onsite role and relocation assistance is available. Job Summary: The Associate Electrical Engineer applies technical knowledge of building services systems across a portfolio of ground-breaking...

  • Senior Quality Engineer.

    4 weeks ago

    Hyderabad, India Medtronic Full time

    Careers that Change Lives We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide. Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship,...

  • Senior Quality Engineer.

    1 week ago

    hyderabad, India Medtronic Full time

    Careers that Change Lives We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Be a part of a community of experts committed to ensuring quality, affordable healthcare worldwide. Come strengthen your specialized skills and enhance your expertise. We’ll support you with the training, mentorship,...

  • Senior Design Engineer

    1 week ago

    india Green Scout Full time

    Job Description Senior Design EngineerOur client are growing and looking for a Senior Design Engineer to join our project team. You will be part of a team responsible for developing and delivering engineering solutions, from feasibility to detailed engineering design, for Electricity Transmission and Distribution Projects (33 kV and above).You will have a...

  • Senior Quality Assurance Engineer

    1 week ago

    hyderabad, India ValueLabs Full time

    Dear Aspirants,We at ValueLabs have an Opening for Senior Mobile Testing Engineer Position . Below is the JD for the same. If interested to explore kindly share the updated profiles to Role: Senior Mobile Testing EngineerRelevant Experience: 7+ YearsImmediate JoinersJob Overview:We are seeking an experienced QA Automation Tester with a minimum of 5 years...

  • senior software engineer

    2 weeks ago

    Hyderabad/ Secunderabad, India timesjobs Full time

    SENIOR SOFTWARE ENGINEERSENIOR SOFTWARE ENGINEER :CLOSED Responsibilities Atleast 3 years of experience with development on a GIS Application (ArcGIS or MapInfo).To work with us in mapping and GIS systems development. Proficiency with data analysis, data acquisition and creation, data manipulation, and editing and querying of GIS data using T-SQL is...

  • Senior Quality Assurance Automation Engineer

    4 days ago

    India IntraEdge Full time

    Senior Automated QA EngineerYrs of exp: 5+Location: Pune/ RemoteIntraedge is looking for a Senior Automated QA Engineer, you will play a critical role in ensuring the quality and reliability of our mobile and web applications. You will be responsible for designing, implementing, and executing automated test scripts, as well as identifying and reporting...