Senior 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 Devices, HealthcareIndustries

Requirements

B.E. or B.Tech in Mechanical Engineering
Minimum 5-8 years of quality engineering experience or equivalence, and overall 8-12 years of experience
Previous experience working in a cross-functional team environment
Good verbal and written communication skills, including protocol/report development and technical presentations
Familiarity with ISO 9001, ISO 13485, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EU MDR, and product-specific industry standards
Familiarity with comparative statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing, ANOVA, parametric and non-parametric analysis
Familiarity with statistical software tools (Minitab, Stat Graphics)
Familiarity with DMAIC or DMADV (DFSS) methodologies

Responsibilities

Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements
Ensure product development projects and changes to existing products comply with FDA Quality System Regulations, EU MDR, and in-house standards
Participate on cross-functional teams to develop product risk management file (risk management plan, Hazard Analysis, DFMEA, and risk management report) per ISO 14971
Review Design History Files and Technical Files for conformance to applicable requirements
Provide hands-on experience on CAPA support and field complaint analysis
Ensure successful transfer of new products to production by assisting in process validation requirements (PFMEA, IQ, OQ, PQ) using statistical tools and techniques
Assist in creation of verification and validation plans, protocols, and reports; oversee testing and analysis for standards and product requirements compliance
Participate and provide input to training on department/division procedures and policies
Participate when appropriate in audits
Deliver presentations to the QA organization on status and issues of assigned projects
Deliver trainings to departments outside of QA
Demonstrate ability to effectively play multiple roles on a cross-functional team (contributor, subject matter expert, leader, facilitator)

Skills

ISO 14971

DFMEA

PFMEA

CAPA

Minitab

ISO 13485

ISO 9001

IEC 60601

21 CFR 820

EU MDR

Process Validation

IQ OQ PQ

Risk Management

Statistical Analysis

Field Complaint Analysis

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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