Premium Employer

i

This company page is being actively managed by Medtronic Team. If you also belong to the team, you can get access from here

Medtronic Verified Tick

Compare button icon Compare button icon Compare
filter salaries All Filters

140 Medtronic Jobs

Sr. Design Quality Enginr

6-12 years

Hyderabad / Secunderabad

1 vacancy

Sr. Design Quality Enginr

Medtronic

posted 1d ago

Job Description

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life Sr Software Design Quality engineer to support tool packages and NPS for CST ET

Careers that Change Lives

This position is for design quality engineering support of software design and development of medical devices, stand-alone software of non-products, non-devices and components including firmware. Facilitate the application of design controls in product development and released product management.

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.

Must Have

  • Review New Product Introduction (NPI) and Released Product Management (Released Products) documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
  • Familiar with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.
  • Ensure that product development projects and changes to existing products are conducted in compliance with IEC 62304, 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.
  • Hanson experience in SW anomaly evaluation and disposition, complaint investigation, NC/CAPA
  • Ensure successful transfer of new products to production facility by assisting in 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.
  • Ensures applicability to SOUP / OTS validations in the product development
  • Participates on CCB to decide upon CR implementation.
  • Assesses the compliance of the software development methodology to the approved process.
  • Participate and provide input to training on department / procedures and policies
  • Hands-on experience on Software Risk Management, Design Controls.
  • Facilitates hazard analysis and SFMEA sessions. Prepares the risk management file.
  • Acts as the subject matter expert on risk management for one or more products/platforms.
  • 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.
  • 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 6-8 years of quality engineering experience or equivalence and overall 8-12 years of experience

Key Technical Competencies

  • Previous experience working in a cross-functional team environment.
  • Familiar with statistical software tools (Minitab, Stat Graphics)
  • 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 and technical 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 13485 Internal Auditor / Lead Auditor Certification
  • Lean Six Sigma Green Belt or Black Belt
  • Comparative Statistical techniques, sampling plans, GRR, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis.
  • Familiar with DMAIC or DMADV(DFSS) methodologies

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the RD lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here


Employment Type: Full Time, Permanent

Read full job description

Prepare for Quality Engineer roles with real interview advice

Top Medtronic Quality Engineer Interview Questions

Q1. Write a Linq expression to fetch the desire results
Q2. Configure the Entity Framewok to connect with database
Q3. 1) What is latest defect, documents we prepare throughout SDLC and STLC 2) in automation: how to handle browser certificate errors in seleni ... read more
View all 25 questions

What people at Medtronic are saying

3.9
 Rating based on 5 Quality Engineer reviews

Likes

The best company I have ever worked in.

  • Salary - Excellent
  • +6 more
Dislikes

Nothing to dislike.

Read 5 Quality Engineer reviews

Quality Engineer salary at Medtronic

reported by 58 employees with 4-8 years exp.
₹6 L/yr - ₹16 L/yr
228% more than the average Quality Engineer Salary in India
View more details

What Medtronic employees are saying about work life

based on 536 employees
84%
75%
33%
93%
Flexible timing
Monday to Friday
Within country
Day Shift
View more insights

Medtronic Benefits

Health Insurance
Job Training
Work From Home
Soft Skill Training
Free Transport
Team Outings +6 more
View more benefits

Compare Medtronic with

Johnson & Johnson

4.0
Compare

Boston Scientific

4.0
Compare

Abbott

4.1
Compare

Siemens Healthineers

4.0
Compare

Philips

3.9
Compare

GE Healthcare

4.0
Compare

Stryker

4.0
Compare

Baxter International

4.0
Compare

Becton Dickinson

4.0
Compare

Zimmer Biomet

3.8
Compare

Poly Medicure

3.7
Compare

Medikabazaar

4.5
Compare

Alcon

3.7
Compare

Careon Healthcare Solutions

3.8
Compare

Essilor

4.1
Compare

Medline Industries

4.0
Compare

SMC Corporation

3.7
Compare

Allengers Medical Systems

3.7
Compare

Trivitron Healthcare

3.3
Compare

Agappe Diagnostics

3.7
Compare

Similar Jobs for you

Quality Engineer at India Medtronic Pvt. Ltd

Hyderabad / Secunderabad

8-12 Yrs

₹ 19-22 LPA

Quality Engineer at India Medtronic Pvt. Ltd

Hyderabad / Secunderabad

8-12 Yrs

₹ 19-22 LPA

Quality Engineer at India Medtronic Pvt. Ltd

Hyderabad / Secunderabad

5-12 Yrs

₹ 7-14 LPA

Senior Quality Engineer at India Medtronic Pvt. Ltd

Hyderabad / Secunderabad

6-12 Yrs

₹ 19-22 LPA

Senior Quality Engineer at India Medtronic Pvt. Ltd

Hyderabad / Secunderabad

8-12 Yrs

₹ 19-22 LPA

Specialist at Vestas Wind Technology India Pvt Ltd

Chennai

10-12 Yrs

₹ 15-18 LPA

Program Manager at ajm softwares

Pune

3-6 Yrs

₹ 11-15 LPA

Senior Quality Engineer at India Medtronic Pvt. Ltd

Hyderabad / Secunderabad

5-12 Yrs

₹ 7-14 LPA

Product Engineer 2 at TE Connectivity India Private Limited

Bangalore / Bengaluru

5-8 Yrs

₹ 13-14 LPA

Program Manager at Amazon India Software Dev Centre Pvt Ltd

Bangalore / Bengaluru

5-9 Yrs

₹ 14-18 LPA

Medtronic Hyderabad / Secunderabad Office Location

View all
Hyderabad Office
G-1, Ground Floor, Shop No.8-2-248A, Maharishi House, Rd Number 3, VST Colony, Banjara Hills, Hyderabad, Telangana Hyderabad
500034

Sr. Design Quality Enginr

6-12 Yrs

Hyderabad / Secunderabad

1d ago·via naukri.com

Quality Engineer II-Hyderabad

6-9 Yrs

Hyderabad / Secunderabad

1d ago·via naukri.com

Senior Enterprise Software Engineer

9-11 Yrs

Hyderabad / Secunderabad

1d ago·via naukri.com

Quality Engineer II

6-9 Yrs

Hyderabad / Secunderabad

1d ago·via naukri.com

Sr. Quality Engineer

5-12 Yrs

Hyderabad / Secunderabad

8d ago·via naukri.com

Senior Quality Engineer

5-12 Yrs

Hyderabad / Secunderabad

8d ago·via naukri.com

Senior IT Technologist

4-6 Yrs

Hyderabad / Secunderabad

9d ago·via naukri.com

Senior Instructional Design Specialist

5-8 Yrs

Hyderabad / Secunderabad

13d ago·via naukri.com

Enterprise Software Engineer - II

2-6 Yrs

Hyderabad / Secunderabad

13d ago·via naukri.com
write
Share an Interview