Principal Software Requirements Engineer - Surgical Robotics
Boston, MA

Job Description

Careers that Change Lives

You will join a team of mechanical, electrical and software engineers responsible for developing Medtronic's Robotic Assisted Surgery platform through commercial launch and production scale-up.

Impact patient outcomes. Come for a job, stay for a career

The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

SURGICAL INNOVATIONS set the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.

A Day in the Life

This position is in the Boston, MA Seaport District, and as the Principal Software Requirements Engineer you will be:

* Responsible for supporting the development of a minimally invasive surgical platform for the R&D organization by developing, managing, reviewing, and documenting software requirements, traceability, associated processes, and the requirements database.


* Responsible for ensuring the overall consistency, testability, and accuracy of requirements content across multiple subsystem and software teams, and the adherence to internal Quality System processes and applicable regulations.


* Equipped with a solid understanding of Software Engineering, Design Control for medical devices, and requirements development.


* Experienced with excellent written and oral communication skills, detailed-oriented and organized, and should be able to work in a multi-site team environment.



As the Principal Software Requirements Engineer you will be:

Creating and Managing Content

Working with the Software Architect and Software Engineering teams to create and maintain the software definition, capturing it in the Software Requirements Documents and Design Control Traceability Matrices, in accordance with applicable Quality System procedures.

Maintaining requirements content and relationships in the requirements development database (JAMA).

Decomposing high-level system and usability requirements into requirements at the software level.

The Program's Requirements Subject Matter Expert (SME)

Facilitate scoping of requirements and setting of business priorities to align product roadmaps and deliverables.

Representing the voice of the customer and the vision of the product throughout the product development process and translating these to the engineering teams in the form of requirements.

Providing status updates and maintaining metrics related to the requirements generation process.

Managing Related Processes

Developing and managing program-wide processes related to requirements generation, revision, review and approval.

Coordinating with stakeholders from across the program to develop, prioritize, and release requirements, including facilitating team reviews, performing gap analyses, and resolving requirements conflicts.

Training and Reviewing Content

Developing and facilitating training sessions about requirements writing and requirements management.

Leading requirements workshops and reviews in a cross-functional setting to support verification activities, traceability, and assessment/analysis of risk.

Reviewing requirements content and traceability to ensure consistency, accuracy, clarity, testability, adherence to Good Documentation Practices (GDP), and applicability with upper level requirements.

Supporting Requirements Verification and Validation

Reviewing associated test methods, protocols, and reports to ensure accurate interpretation of requirement intent applicability, coverage, and adequacy for the verification and validation of related requirements.

Participating in reviews of negative test outcomes and ensuring requirements are updated appropriately, with changes clearly documented and justified in accordance with the Quality System.

Must Have: Minimum Requirements:

* Bachelor's degree required


* Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience.



Nice to Have:

* Minimum of B.S. degree in Engineering, Math, Computer Science, or related field; 7+ years of relevant experience.


* 7-10+ years of experience in medical device development, preferably with electro-mechanical, robotic, or software applications/products.


* 5+ years of direct involvement with product requirements development and verification.


* Knowledge of principles and applications of biomechanics, mechatronics, electrical, mechanical, and software development.


* Advance knowledge of Software Engineering and requirements-driven product development principles, including requirements writing and analysis techniques.


* Demonstrated capability to develop and manage requirements.


* Communicates effectively with cross-functional and multi-site teams.


* Demonstration of good documentation practices. Strong analytical and problem-solving skills.


* Ability to work independently and collaborate as a member of a cross-functional team.


* Understanding of IEC 62304, ISO 13485, ISO 14971


* Has experience using a variety of office and engineering software, including MS Office, requirements management tools like DOORS or Jama, Task tracking tools like Jira or Test Track.


* Preferred; Understanding of medical device industry, clinical anatomy, and competitor products.


* Preferred: Awareness of clinical and regulatory pathways, IP and internal processes.



Working Environment/Physical Activities:

Work usually performed in an office setting, laboratory, and/or surgical laboratory with frequent sitting, walking, standing, kneeling, crouching, crawling, balancing, stooping, and occasional climbing.

Oral and auditory capacity enabling interpersonal communication as well as communication through automated devices such as the telephone or over frequent web-based meetings.

Light physical effort required by handling objects up to 20 pounds occasionally* and/or up to 10 pounds frequently.

Potential travel between Medtronic sites.

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. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

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 Day in the Life 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.

EEO

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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees .