Software Reliability Engineering Program Manager (Quality Core Team Member) at Medtronic

Newton, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor's degree and a minimum of 5 years of relevant experience OR Advanced degree with a minimum of 3 years of relevant experience
Preferred: Minimum of 5 years of experience across any of the following disciplines: software development or testing, quality or reliability engineering, or field/research experience in a cardiac electrophysiology lab
Preferred: At least 2 years of product development experience within the medical device industry

Responsibilities

Support software quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485
Serve as the Quality Core Team Member for Affera software releases
Coordinate quality team members and ensure accountability for completing functional work within program deadlines
Review and approve Design History File and other documentation related to software and security, including plans, change assessments, requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling. Ensure all documentation meets reliability standards and follows QMS processes
Develop and review documentation for traceability, testability, and compliance according to standard operating procedures
Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned
Participate in software risk analysis and defect assessments
Influence and analyze software quality metrics for assigned programs, ensuring continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability
Provide software quality support for post-market activities and analysis, including issue assessments, health risk assessments, and CAPAs. Ensure ongoing compliance and reliability of released software products
Recommend design or test methods to achieve appropriate levels of product reliability and security. Propose changes to design or testing as necessary to improve software and/or process reliability
Analyze preliminary plans and develop reliability engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives for assigned programs
Review and support strategies for product security testing
Obtain and maintain hospital credentialing to attend live EP cases 2–3 times per year to enhance workflow and product knowledge
Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements

Skills

Key technologies and capabilities for this role

IEC 62304ISO 13485FDA CFRMDRDesign History FileSoftware VerificationSoftware ValidationRegulatory ComplianceProgram ManagementQuality Assurance

Questions & Answers

Common questions about this position

Is this a remote position or does it require onsite work?

The role requires working a minimum of 4 days a week onsite to foster professional growth and cross-functional collaboration.

What are the main responsibilities of this role?

Responsibilities include supporting software quality and reliability for Cardiac Ablation Solutions products, serving as Quality Core Team Member for Affera software releases, reviewing and approving Design History File documentation, and participating in risk analysis and post-market activities.

What regulatory standards must be complied with in this role?

Compliance with FDA CFR, MDR, IEC 62304, and ISO 13485 is required.

What is the company culture like at Medtronic?

Medtronic emphasizes bold ideas with speed and decisiveness, putting patients first, fostering professional growth and cross-functional collaboration through in-person exchanges.

What makes a strong candidate for this Software Reliability Engineering Program Manager role?

A strong candidate blends technical expertise with passion for quality, compliance, and patient outcomes, has experience with software development processes, regulatory standards, and can coordinate teams while influencing quality metrics.

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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