Senior Software Systems Engineer-Medical Device
Kforce Inc.

Job Info

---

RESPONSIBILITIES:

Kforce's client, a growing and established Medical Device Technology Company is seeking a Senior or Principal Software V&V Systems Engineer. We are working directly with the Hiring Manager on this exclusive search assignment. The company offers a competitive compensation package including base salary, annual bonus, etc. This position is mostly remote. Occasionally would need to have the ability to come into the office occasionally.In this role, your principal work responsibilities will be to define and manage product and software requirements based on User Needs. You will be responsible for defining verification and validation testing approaches, maintaining the Requirements Trace Matrix and Product Compatibility Matrix, and leading integration of systems into production. The Software Systems Engineer will be the functional owner of product requirements and system integration for the company's product family from cradle-to-grave throughout the entire product lifecycle. Your responsibilities will also include executing test protocols, documenting test results, and Intended Use Validation (IUV). Your job will be to ensure system-wide quality and reliability. You will work closely with biomedical, software, and hardware engineering as well as quality assurance.Responsibilities:

• Supporting the different components that support the products such as base stations, PC, and the cloud
• Work directly with R&D Biomedical to translate user needs into system and subsystem requirements (PRDs)
• Work with Software Engineering to assure proper translation of PRDs into SRSs
• Work cross-functionally with R&D, RA, and QA to ensure that all requirements have a compliant verification and/or validation plan
• Maintain the Requirements Trace Matrix
• Maintain the Product Compatibility Matrix
• Lead the V&V efforts with external and internally stakeholders
• Medical device verification and validation

REQUIREMENTS:

• A Bachelor of Science or MS degree in Computer Science, Systems Engineering, or related Scientific, Technical, or Engineering discipline is required for this position
• Minimum of 5-8+ years of systems engineering, software V&V at either the embedded software or application software and/or both
• Experience in an FDA regulated medical device manufacturing environment
• Experience in medical device verification and validation
• Experience with product compatibility matrix
• Experience with FDA regulated quality management systems (21 CFR 820, ISO 13485)
• Familiarity with the medical device design control and development process
• Familiarity with software development life cycle and IEC 62304
• Prior experience developing test plans and test cases for system and software testing
• Systems and integration testing experience
• A commitment to quality
• Ability to work well in cross-functional teams (across geography and culture) with a group of people with diverse skill sets and personalities
• Team player, flexible and adaptable

Nice to haves but not required:

• Implantable medical device experience such as pacemakers, artificial hearts, infusion pumps, diagnostic equipment, or other technologies with design/manufacturing considerations relevant to Canary's offerings
• Medical mobile applications experience
• Someone that comes from a software development background such as embedded and/or application level is a plus but not required
• Cloud computing experience
• SDLC knowledge
• Cyber security testing experience
• Test automation experience
• Embedded systems experience
• Intended Use Validation (IUV) experience

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

This job has expired.