Lead Software Quality Engineer

Still River Systems is building the Monarch 250™ Proton Beam Radiation Therapy System, a practical, cost-efficient, single-room PBRT system scaled for use at most cancer centers. Designed using state of the art engineering techniques and materials, the heart of the Monarch 250™ System is a compact, superconducting high field magnet which directs a proton beam toward a precisely defined isocenter.

Included in the Monarch 250™ PBRT System is a cyclotron, the proton beam delivery system, a treatment couch with pendant control, a radiographic patient positioning system, proton beam treatment planning, and a link to a treatment record and verify system.

 Lead Software Quality Engineer

 Still River Systems is looking for an experienced Software Quality Engineer to lead the Software Testing of our proton therapy device software.

 Job Responsibilities:Coordinate, recruit, and participate in all software verification and validation (V&V) activities to ensure that software is validated in accordance with established requirements.Work with the Quality and Regulatory Department to insure that the V &V process conforms to requirements and guidelines from US FDA, other regulatory bodies and department procedures.Participate in code reviews and code walkthroughs.Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications.Develop software verification and validation test plans, protocols, and verification and validation test data & reports.Coordinate and participate in the software testing team.Organize the software testing environment.

The candidate should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation. Knowledge of software testing strategies, verification and validation procedures and rigorous medical or avionics software development life cycles are preferred. 

The Job requires working with and understanding of Windows XP, Linux, VxWorks, PLC programming, GUI and windows development environments.

Qualifications:

 Successful candidates will have:Bachelor’s Degree in computer science, computer engineering, software engineering, or a directly related field relevant discipline with 5-10 years in a similar position responsible for software quality assurance duties.  Excellent writing and communication skills are critical. Minimum 5 years experience directly validating medical (and other regulated) device software. Experience with medical device development under FDA Quality Systems Regulations, European Union Medical Device Directive (93/42/EEC), CE Marking process, and ISO 13485:2003 Quality Systems is a plus. Experience and understanding of IEC 62304:2006 is a plus.Familiarity with automated testing tools and scripting languages is a plus.Excellent written and verbal communications are essential.

No phone calls, please.

 

Still River Systems, Inc. offers competitive compensation and benefits. 

Still River Systems, Inc. is an equal opportunity employer.