Position Title: Software Quality Engineer

Position Type: Full Time

Job Type: Experienced

Reporting To/Department: Manager of Device Quality and Usability

Location: Boston, MA 

Seeking a highly motivated Software Quality Engineer to work in a dynamic, fast-paced start-up environment on a combination drug-device product. Developing a breakthrough surgical guidance technology platform consisting of a proprietary drug that is activated by the micro-environment of cancerous tumors, a custom fluoroscope that allows a surgeon to visualize activated drug, and a software system that gives a real-time prediction of tissue likely to be cancerous. This is an exciting opportunity to join a company that has received excellent press and generated promising clinical data while still in its early development.

The successful candidate must have a thorough understanding of Design Controls, Software Lifecycle and Software Validation in the medical industry. The successful candidate is methodical, detail-oriented, integrates well into existing company processes, and takes ownership of software quality deliverables.

The Software Quality Engineer will be an integral part of the cross-functional team to ensure our software is developed compliance with regulatory and company requirements. The Software Quality Engineer will guide the Software Development team throughout the Software Lifecycle design process and ensure product software is appropriately validated.

Responsibilities

• SME of Software Lifecycle Design SOP and ensure software elements of the QMS are up to date with the relevant regulatory requirements
• Serve as a Core Team Member to review Software DHF documentation and provide strategic input to the Software Development team; assist with the execution of Software V&V Test Plans
• Work closely with Software Development to lead Software Risk Assessment activities
• Ensure all Design Control deliverables are met according to the Software Development Plan
• Monitor Change Control activities associated with product software
• Collaborate with the sustaining engineering team to investigate NCMRs, CAPAs, deviations, and complaints relating to software
• Assess and lead Computer System Validation (CSV) efforts for non-product software under new FDA rubric for Computer Software Assurance (CSA)
• Show exceptional attention to detail and ability to effectively and accurately document test results

Qualifications

• BS in Biomedical, Software, or Computer Engineering or other technical discipline
• Minimum 3 years of experience in the medical device field, including experience with the Software Lifecycle regulatory guidance
• Experience utilizing Software Development tools and associated systems for requirements management preferred
• Experience with medical imaging, fluorescence imaging and/or optoelectronics preferred
• Familiarity with IEC 62304, ISO 14971, 21 CFR 820, ISO 13485, IEEE standards preferred

  Critical Competencies for Success

• Detail-oriented and highly organized
• Must be able to work independently and as part of a team, learn quickly, and take on responsibilities outside of this scope of work, as necessary
• Must have strong patient and user focus with patient outcomes in mind
• Must be resilient and focused with a knack for navigating complex and occasionally ambiguous environment
  

Position Type/Expected Hours of Work

• This is a full-time position, 40 hours per week. Days and hours of work are Monday through Friday during business hours. Occasional evening and weekend work may be required as job duties demand.

COVID Policy

• We have an implemented and strictly enforced COVID Policy that’s intended to keep all employees safe when working on-site.
• We have also created an internal COVID Task Force to stay up to date on all COVID developments and to adjust our policy appropriately based on such information.