Sr. Software Quality Engineer
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Job Location:
Newton, MA - USA
Monthly Salary:
$ 102400 - 153600
Posted on:
25-10-2025
Vacancies:
1 Vacancy
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.
A Day in the Life
At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we -person exchanges are invaluable to our work. Were working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Join Medtronic as a Senior Software Quality Engineer and be at the forefront of transforming lives through advanced medical technology! In this dynamic role youll work alongside a team of engineers and cross-functional partners to drive quality for design development and maintenance of software for Affera cardiac electrophysiology systems. By blending technical expertise with a passion for quality compliance and improving patient outcomes youll have the opportunity to impact global healthcare as the usage of Affera grows rapidly worldwide.
Primary Responsibilities
Support software quality and reliability efforts for Cardiac Ablation Solutions products ensuring compliance with regulatory standards such asFDA CFR MDR IEC 62304 andISO 13485.
Serve as member of the extended quality team for Affera software releases used for mapping and navigation in electrophysiology procedures. Collaborate with other quality team members to take accountability for completing assigned functional work within program deadlines.
Review and approve various Design History File documents related to software and security including 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 as assigned.
Contribute to tracking software quality metrics for assigned programs supporting continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability.
Provide software quality support forpost-market activities and analysis including work supporting issue assessments health risk assessments and CAPAs.
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.
Contribute to reliability engineering program strategies to achieve Medtronic customer and regulatory reliability objectives for assigned programs.
Review and support strategies for product security testing as assigned.
As available attend a live EP case at least once per year to enhance workflow and product knowledge. Regularly participate in virtual live case learning opportunities.
Collaborate with cross-functional teams including R&D regulatory affairs and clinical teams to ensure alignment on quality and compliance requirements.
Travel Requirement: <10%
Required Qualifications
Bachelors degree and a minimum of 4 years of relevant experience
OR Masters degree with a minimum of 2 years of relevant experience
OR PhD with 0 years relevant experience
Preferred Qualifications
At least 1 year of experience supporting product development.
Ability to perform simple coding tasks and effectively read interpret and understand existing software code.
Excellent written and oral communication skills.
2 years of medical device or other regulated industry (such as defense or aerospace) experience.
2 years of industry experience working with a software development team.
Experience creating risk analysis documentation such as FMEAs and FTAs.
Experience using or working with products built on Python Qt Docker and Linux.
Strong knowledge ofcybersecurityandthe software lifecycle within regulated environments including design development and post-market support.
Experience with cardiac and electrophysiology medical specialties.
Advanced degree in a relevant field.
Certification inquality systemsorregulatory affairs(e.g. Six Sigma ASQ or similar).
#LI-MDT
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.
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.
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
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 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:
Senior IC
Key Skills
- Apache Commons
- Compensation
- Customer Support
- ABAP
- ERP
- Art
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
