• This position has the opportunities to work with more senior software quality engineers to support all software lifecycle related activities:
• New Product Development lifecycle, such as the design, development, test, and market release of Product software used in real time Navigation System in our Neuroscience team;
• Post Market Release lifecycle, such as remediation, CAPA, and other activities as assigned.

Responsibilities may include but not limited to the following activities, with mentor/coach/guidance from more senior Software quality engineers:

• Supports product quality ensuring the implementation of cutting-edge technology for medical devices is safe, effective, and compliant with regulations, standards, and industry practices.
• Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
• 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.
• Collaborate with test engineering on verification and validation strategies, review and approve test protocols and reports.

Required Qualifications:

• Bachelor’s Degree in Engineering, Science or technical field with 4 years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field with 2 years of work experience in Engineering and/or Quality

Nice to Have

• Experience in the medical device industry
• Experience with FDA Quality System Regulations, Medical Device Directive, ISO 13485, ISO 14971, and ISO 62304 standards
• Navigation systems experience preferred
• Excellent oral and written communication skills