JobID: 382497
Our client in Oakland, CA is seeking a Software Systems Engineer/Technical Product Manager for a long-term contract position. This exciting role will have you working on advanced R&D product development in the medical device industry. The Software Systems Engineer/Technical Product Manager should have experience in medical software product development with experience dealing with the regulatory, quality and safety aspects, plus experience and thorough understanding of the software development process required by FDA.
Responsibilities include:
• Foster collaboration with SW product designers, engineers, quality assurance, and marketing to explore, prioritize, and launch solutions.
• Work with the development team to ensure that SW product requirements are understood and built accordingly.
• Translate the SW product’s strategy into detailed requirements for final product development.
• Design and define the SW product functionality. This includes defining the user interface and workflow, specification of product metrics and working with R&D scientists on the technical specifications for the system.
• Outline the SW product vision, product strategy, and product roadmap.
• Support SW engineering team to ensure development goals are met.
• Use a software development methodology, like Agile, to optimize processes.
• SW Hazard, safety and risk assessment including evaluation of mitigating measures. This includes a broad range of factors including:
i. Gauge the risk of misunderstanding causing improper use.
ii. Evaluating the effects of improper use, e.g. effect of pressing the wrong button.
a. Clinical hazards and risk assessment.
b. Design failure analysis
c. Cyber-security risks
Requirements and Qualifications:
- Bachelor’s degree or higher in computer science, information technology or related field
- Evidence of continuing education, such as technical certifications, a plus
- Experience working in an FDA regulated industry (SW development) is required.
- Minimum 7 years’ experience.
- Local to the Bay Area preferred. Work will be remote during COVID lockdown.
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