Sr. FW/SW Verification Engineer (Medical device)

Position/Title: Senior FW/SW Verification Engineer

Department: R&D

Supervisor: VP of R&D

Job Summary: This role of FW/SW Verification Engineer will be responsible for performing all V&V activities related to FW and SW related to the next generation of products designed by company. It is an essential role to the growing R&D team to augment the design expertise already available to create novel products. This person will be part of the R&D team to develop and be central to verifying the next set of FW/SW solutions to deliver a robust product for the urology market. A solid understanding of FW/SW development and verification as relates to 62304 is required. The person will develop test plans, test cases for all the products, lead code reviews, perform integration testing and ensure that the software is deployed in the field with risks mitigated to ensure the product is of great quality for the patients. The role would also require releasing all related documents (plans, engineering reports, system and software ICDs, test reports, etc.) in the QMS system.

Responsibilities/Tasks

• As Senior FW/SW Verification Engineer you will be responsible for:
• Develop interface control documents for the system as well as sub-systems
• Develop test cases for implant and accessories FW
• Perform unit testing for each module
• Perform integration testing for the system and all interfaces
• Perform documentation (plans, reports) for reporting V&V activities
• Perform occasional coding work to help the development team
• Perform reviews and conduct design dossier reviews as needed
• Perform FW/SW risk assessments for the codebase
  
  

Qualifications

• 10 years of relevant experience in Medical Devices, preferably Class 3
• Part of product development team with approval and market release of the product
• MS or equivalent degree
• Medium proficiency in code development (able to code within existing framework, sustain and
• debug code)
• Strong capabilities in documentation
• Can read timing diagrams and translate to FW/SW code, and vice versa
• Languages: Embedded C, C , C#
• Understanding of regulatory constraints and FDA guidance
• Basic understanding of cybersecurity
• Go getter attitude
• Works independently
  
  

Preferred Qualifications

MPLab IDE and IPE environments

Visual Studio Windows Forms Development

Led a team for FW verification activities for Class 3 devices

Basic understanding of EE principles

Worked on custom communication protocols

WiFi and cloud related code verification experience

Benefits

• Medical Insurance
• Dental Insurance
• Vision Insurance
• 401K with Employer Matching
• Paid Time Off
• Paid Holidays
• Professional Development Reimbursement
• Annual Bonus Eligibility