Principal Software Quality Engineer InfrastructurePostMarket
Job Location:
Newton, MA - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
Join Medtronic as a Principal Software Quality Engineer - Infrastructure/Post-Market and take a leading role in ensuring the safety reliability and compliance integrity of Affera cardiac electrophysiology systems software used in live clinical environments this high-impact position you will drive complex issue evaluations and health risk analyses based on realworld device performance.
This role partners closely with field staff observing issues customer quality experience (CQXM) and quality trending personnel Software Quality and R&D Engineers from product teams Medical Safety and Clinical teams to analyze software behavior observed in the field assess risk and guide highimpact postmarket decisions and actions. As a technical and compliance authority you will shape investigation quality assessment rigor product reliability and regulatory audit readiness as Affera adoption continues to expand globally.
Primary Responsibilities
Build andmaintaindeep systemlevel understanding of Affera software performance in clinical use through regular engagement in live case observations.
Lead and execute postmarket software issue evaluations including complaint analysis risk file assessments and impact determination.
Serve as a principal author of Health Risk Assessments (HRAs) for software anomalies and corrections ensuring clear linkage between observed software behavior risk files and systemlevel impacts.
Act as a quality and compliance authority for selected softwarerelated CAPAs guiding root cause analysis mitigation strategy development and verification of effectiveness.
Author review and approve postmarket quality system documentation including issue evaluations CAPA records risk file updates and field action support materials.
Drive softwarefieldcorrective action intake and follow-on actions for the CAS OU.
Ensure postmarket documentation is auditready technically defensible and aligned with FDA EU MDR and global regulatory expectations.
Partner closely with crossfunctional teams to track metrics that drivetimelyand compliant resolution of software issues.
Provide program management/coordination support technical mentorship and strategic guidance to other engineers supporting complaint handling investigations and postmarket surveillance activities.
Influence enterpriselevel postmarket software quality processes as needed.
Represent postmarket software quality during inspections audits and internal reviews providing preparation support clear technical and regulatory rationales andassistance.
Travel Requirement: <20%
Required Qualifications
Bachelors degree anda minimum of7years of relevant experience
ORMastersdegree witha minimum of5years of relevant experience
OR PhD with3years relevant experience
Preferred Qualifications
Bachelors degree in software engineering computer engineering electrical engineering biomedical engineering ora relatedtechnical field.
7 years of experience in software quality reliability engineering postmarket surveillance software engineering or regulated medical device development
Strong working knowledge of medical device quality systems and regulations including FDA CFR MDR ISO 13485 and IEC 62304.
Ability to read interpret and evaluate software behavior logs and technical data to support investigations.
Excellent analytical and written/oral communication skills.
Capability to secure hospital credentialing for clinical sitevisits.
Experiencesupporting postmarket surveillance or activities for complex medical device software on capital equipment.
Experience leading postmarket softwareissueevaluations risk assessments and CAPA activities.
Experience working with risk analysis documentation such as FMEAs and FTAs.
Experience working with cardiac electrophysiology medical devices.
Skilled in program management and work/metric tracking across complex systems and multiple products.
Advanced degree in a relevant technical or quality discipline.
Quality or regulatory certifications (ASQ Six Sigma or similar).
#LI-MDT
For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.
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.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
U.S. Work Authorization & Sponsorship
At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Join us in our mission to alleviate pain restore health and extend lifewhere your unique background and perspective are valued.
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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
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 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D 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.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Staff IC
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
