Senior Software Quality Engineer

Medtronic - Littleton, MA4.0

Careers that Change Lives

Your dedication is important to our customers and, most importantly, to their patients.

Medtronic is currently seeking a Sr Software Quality Engineer.

This position has the responsibility and authority to work with minimal guidance to support the design, development, test, and market release of Product software used in real time Imaging System. Contribute to non-product software process, test equipmenet development and validation process. Develop and assess the quality programs and systems of Medtronic Navigation to applicable standards.

Do meaningful work, make a difference, and improve lives — starting with your own.

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

A Day In The Life

  • Actively participate in product development cycle by reviewing software project documentation and participating in product risk assessments
  • Work cross-functionally to implement improvements to the software life cycle, including the establishment of risk management as an integral part of the quality management system as an overall framework for the application of appropriate software engineering methods and techniques
  • Create and revise Standard Operating Procedures (SOPs) and other documentation to support the Quality System related to software and system design
  • Identify and implement software process metrics for the software product development life cycle. Develop, analyze and monitor metrics pertaining to software defects uncovered during development, testing and post-release
  • Review documentation for validation and maintenance of non-product Software utilized in production environment, automated test equipment and quality system. Update policies and SOPs to ensure they comply with applicable regulations and standards
  • Recommend and lead corrective and preventive actions to improve software product quality. Ensure documentation and analysis are completed in a timely manner in accordance with FDA and European Regulatory agency standards and procedures
  • Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives
  • Conduct risk management activities and recommend an appropriate course of action via CAPA systems
  • Participate in Post Market Monitoring activities such as complaint investigation, complaint trending etc.
  • Follow all Quality System Practices as defined by Medtronic Navigation’s Littleton’s practices, policies and Standard Operating Procedures (SOPs) to ensure that FDA, ISO and European Medical Device quality standards and regulations are met where applicable
  • Participate in DHF audits and conduct independent review of product verifications and validations.
Responsibilities may include the following and other duties may be assigned.

Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
Defines appropriate measures to ensure product quality.
Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
Reviews include applicable specifications, materials, tools, techniques, and methodologies.
Provides or directs verification and validation of software system requirements, traceability, and testability.
Must Have: Minimum Requirements

  • Bachelors in Engineering or similar related field, but Computer Science Preferred
  • 4+ years of previous experience in an engineering position with Bachelors
  • 2+ years of previous experience in an engineering position with Masters
  • Experience in a Regulated environment
Nice to Have – (Preferred Qualifications):
  • 7+ years of previous experience in an engineering position with Bachelors
  • Working knowledge of FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards
  • Formal training in Lean and Six Sigma methods combined with project deployment experience at the green belt or greater level is highly desirable
  • Some knowledge in one or more of the following areas: LabVIEW, C/C++, Linux/Unix, Java, External Communication (RS-232, TCP/IP, wireless).
  • Excellent oral and written communication skills
  • Ability to work in a team environment
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.