Pre-Market Software Safety Engineer Level II - CRM
Pre-Market Software Safety Engineer Level II - CRM
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$ 84000 - 126000
1 Vacancy
Job Description
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
Pre-Market Software Safety Engineer IICareers That Change Lives
At Medtronic we push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems make progress and deliver meaningful innovations.
Cardiac Rhythm Management (CRM) Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure.
We are comprised of three businesses:
Cardiac Pacing Therapies
Cardiovascular Diagnostics & Services
And Defibrillation Solutions
We prioritize people in everything we do remaining at the forefront of innovation to treat more patients. Our commitment to operational excellence ensures we deliver exceptional experiences for those impacted by our therapies.
In this exciting role as a Pre-Market Software Safety Engineer II you will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients clinicians regulators and the business.
This position offers an exciting opportunity to drive software reliability and safety engineering within dynamic new product development teams for R&D. The candidate will be a pivotal member of cross-functional teams serving as the go-to expert for reliability safety and quality functions.
As a core member of the R&D project teams the Pre-Market Software Safety Engineer II will drive excellence in quality and reliability programs. This dynamic role involves leading Design for Reliability (DfR) initiatives offering technical expertise actively participating in design and risk reviews and shaping the development of cutting-edge technologies. Collaborating with multidisciplinary teams the position is pivotal in ensuring that innovative solutions meet the highest safety and reliability standards fostering impactful advancements in patient care.
This position is in Mounds View MN. within the Cardiac Rhythm Management (CRM) unit. 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. We are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects.
We believe that when people from different cultures genders and points of view come together innovation is the result and everyone wins. Medtronic walks the walk creating an inclusive culture where you can thrive.
A Day in the Life
In general the following responsibilities apply for the Pre-Market Software Safety Engineer II role. This includes but is not limited to the following:
- Leverage relevant medical technology experience to ensure the practical applicability and safety of our products in real-world settings.
- Completes risk severity and occurrence determination and analyze risk benefit profiles for cardiac medical products.
- Completes risk analysis studies of new design and processes.
- Ensures that corrective measures meet acceptable reliability/safety standards.
- Analyzes preliminary plans and develops reliability/safety engineering programs to achieve company customer and governmental agency reliability/safety objectives.
- Support technical reliability/safety studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
- Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability and safety.
- Proposes changes in design or formulation to improve system and/or process reliability and product safety.
Qualifications
Must Have - Minimum Requirements
TO BE CONSIDERED FOR THIS ROLE PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME
- Bachelors degree in engineering math science or technical discipline
- Minimum of 4 years of work experience in engineering and/or quality OR advanced degree in engineering science or technical field with 2 years of work experience in engineering and/or quality.
Nice to Have
- Advanced degree in engineering or science.
- Proven understanding of product reliability/safety engineering principles.
- Strong understanding of and experience in the application of statistics.
- Experience in ahighly regulatedindustry preferably implantable medical devices.
- Experience with 21 CFR Part 820 (Quality System Regulation) ISO 13485 etc.
- Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g. PHA HA FTA DFMEA).
- Certified Software Reliability Engineer (CSRE) certified.
- Exposure to or experience working in or with design quality regulatory clinical and/or manufacturing.
- Experience in design maintenance or continuation engineering of released software or software systems including mobile applications.
- Knowledge of Design for Reliability (DfR) Design for Reliability and Manufacturability (DRM) Design for Six Sigma (DFSS) Design for Lean Sigma (DFLS) and/or robust design practices.
- Previous clinical field experience specifically with cardiac rhythm management products.
About Medtronic
Together we can change healthcare worldwide. At Medtronic we push the limits of what technology therapies and services 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 exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.
Physical Job Requirements
PHYSICAL JOB REQUIREMENTS - 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. (ADA-United States of America)
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.
Employment Type
Full-Time
