30 days old

Principal Software Test Engineer (Santa Rosa, CA or Remote within the US)

Medtronic
Santa Rosa, CA 95404 Work Remotely
Principal Software Test Engineer (Santa Rosa, CA or Remote within the US)

Location:

Santa Rosa, California, United States

Requisition #:

210008PQ

Post Date:

Apr 05, 2021


**Principal Software Test Engineer**

**210008PQ**

**Santa Rosa, CA or Remote within the US**


**Careers That Change Lives**


In this exciting role as a software test engineer you will support the design, development, test, release, and maintenance of medical devices through the application of electrical and software engineering principles.


**Coronary Renal Denervation**


Coronary Renal Denervation therapies are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational renal denervation therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic.


**A Day in the Life**


+ Actively participates in the product development cycle by leading project software quality deliverables

+ Researches, develops, and designs test methods for programmable electronics, equipment, and systems for Renal Denervation RF generators based on hardware and software requirements

+ Executes verification and validation activities, and authors reports in support of the design history file and regulatory submissions

+ Leads the development and qualification of tools used to create and test medical devices.

+ Supports sustaining engineering activities including qualifying replacement parts, change impact and regression analysis

+ Leads resolution to product complaints and/or safety issues and collaborates with other functions to improve customer satisfaction and deliver products that meet or exceed customer needs and expectations

+ Develops and assesses the quality programs and systems to applicable internal and external standards and regulations, and accepted engineering practices, such as IEC 60601-1, IEC 60601-1-2, and IEC 62304


Responsibilities may also include the following and other duties may be assigned.


+ Develops, coordinates and conducts technical reliability 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.

+ Completes risk analysis studies of new design and processes.

+ Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.

+ Ensures that corrective measures meet acceptable reliability standards.

+ Analyzes preliminary plans and develops reliability engineering programs to achieve company, customer and governmental agency reliability objectives.

+ May develop mathematical models to identify units, batches or processes posing excessive failure risks.

+ As necessary, proposes changes in design or formulation to improve system and/or process reliability.

+ May determine units and/or batches requiring environmental testing, and specifies minimum number of samples to obtain statistically valid data.


**Must Have: Minimum Requirements**

Bachelors degree in Engineering, Science or Technical field with 7+ years of experience in Quality and/or Engineering OR Advanced degree in Engineering, Science or Technical field with 5+ years of experience in Quality and/or Engineering


**Nice to Have**


+ Electrical Engineering, Computer Science, Biomedical Engineering or related STEM degree


+ Working knowledge of C and object-oriented programming (Java, C++, etc.), scripting languages (e.g., Python, PERL, Shell)

+ Experience with requirements management, version control, and issue tracking tools

+ Working knowledge of regulatory processes to ensure compliance with existing test procedures

+ Expert knowledge of modern, iterative software design processes and development practices

+ Strong oral and written communication skills

+ Strong leadership skills and ability to work in a team environment

+ Highly motivated hands-on engineer with a proven record of meeting timelines and goals

+ Must possess strong analytical problem-solving skills

+ Working knowledge of IEC60601 and familiarity with IEC 62304 and other relevant medical device standards

+ Experience in Design Assurance or Quality roles

+ Medical device industry knowledge, including VV activities with a focus on automation and process improvement

+ Experience with test station design and development

+ Knowledge in electrical and electronic manufacturing processes as they apply to the design process

+ Previous experience with process qualifications

+ Previous experience with product impact assessments and CAPAs

+ Skilled in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes

+ Working knowledge of Lean, Six Sigma, or Design for Reliability and Manufacturing

+ Hands on experience in dFMEA, pFMEA, risk analysis and management

+ Experience with embedded microprocessor-controlled equipment development

+ Demonstrated ability to build effective relationships across organizations and geographies

+ Working knowledge of Quality System Regulations (QSR), design control systems, ISO 13485 and GMP

+ Excellent judgment and strong critical thinking skills


**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


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)


Travel less than 10%
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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2021-04-08 Expires: 2021-05-15

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Principal Software Test Engineer (Santa Rosa, CA or Remote within the US)

Medtronic
Santa Rosa, CA 95404

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