Sr Design Quality Engineer at Medtronic

Hyderabad, Telangana, India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

B.E. or B.Tech in Software/Electrical Engineering
Minimum 6-8 years of quality engineering experience or equivalence, and overall 8-12 years of experience
Previous experience working in a cross-functional team environment
Familiar with ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR, and product-specific industry standards
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
Strong in software design and development, software verification and validation activities
Computer literate with experience in PCs, networks, applications, and software development life cycle
Knowledge in cybersecurity
Travel may be required

Responsibilities

Review New Product Introduction (NPI) and Released Product Management documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements
Hands-on experience with tools package release process for both Software & Hardware tools/accessories
Review non-product/off-the-shelf tools for products
Experience in software or hardware design transfer process for tools or products
Ensure product development projects and changes to existing products comply with IEC 62304, FDA Quality System Regulations, EU MDR, and in-house standards
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 or review of verification and validation plans, protocols, and reports; oversee testing and analysis for standards and product requirements compliance
Hands-on experience in SW anomaly evaluation and disposition, complaint investigation, NC/CAPA
Ensure successful transfer of new products/tools to production facility by assisting in development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques
Review Design History Files and Technical Files for conformance to applicable requirements
Participate when appropriate in audits
Ensure applicability to SOUP/OTS validations in product development
Participate and provide input to training on department/procedures and policies
Hands-on experience on Software Risk Management and Design Controls
Develop templates and training based on quality system regulations, applicable standards, and guidance
Independently review all SW deliverables to ensure compliance with development process and standards
Deliver presentations to the QA organization on status and issues of assigned projects; deliver training to departments outside of QA
Provide Quality support to facilitate resolution of product complaints and/or safety issues
Provide support to the Regulatory Department in writing technical submissions

Skills

Key technologies and capabilities for this role

ISO 13485IEC 62304ISO 14971IEC 6060121 CFR 82021 CFR 11EUMDRDFMEAPFMEAIQ OQ PQRisk ManagementDesign TransferSoftware QualityHardware QualityCAPASOUPOTS Validation

Questions & Answers

Common questions about this position

What education and experience are required for this Sr Design Quality Engineer role?

A B.E. or B.Tech in Software/Electrical Engineering is required, along with a minimum of 6-8 years of quality engineering experience or equivalent, and overall 8-12 years of experience.

What key skills and standards knowledge are needed for this position?

Candidates need hands-on experience with software risk management, design controls, tools package release processes, SW anomaly evaluation, and familiarity with standards like ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, and EUMDR.

Is previous cross-functional team experience required?

Yes, previous experience working in a cross-functional team environment is required.

What is the employment type for this role?

The position is full-time.

What makes a strong candidate for this Sr Design Quality Engineer position?

Strong candidates will have 8-12 years of overall experience including 6-8 years in quality engineering, a degree in Software/Electrical Engineering, hands-on expertise in software design quality processes, compliance with medical device standards like IEC 62304 and ISO 13485, and proven cross-functional team collaboration.

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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