Job Description
Job Description
Associate Systems Engineer - Software to drive software product definition, including requirements, system architecture design, risk analysis, and solution implementation to meet IVD standards. This role focuses on advancing cancer diagnostics through state-of-the-art testing automation, providing over 250 cancer tests and associated instruments globally.
Responsibilities
- System Lifecycle Management: Apply Systems Engineering to software product definition, requirements, risk analysis, and testing.
- Project Execution: Manage software requirements, risk analysis, configuration, defect management, and verification/validation.
- Industry and Technology Analysis: Research trends, emerging technologies, and competitive products to identify opportunities for software differentiation.
- Cross-functional Collaboration: Work with R&D, Marketing, Operations, Quality, and Regulatory teams to ensure alignment.
- Customer-Focused Innovation: Engage with business leaders and Voice of Customer (VoC) representatives to align technical solutions with customer needs.
- Technical Problem Solving: Analyze complex technical challenges, present solutions, and facilitate informed decision-making.
Who You Are
- Educational Background: Bachelor's degree in Engineering, Biomedical Sciences, or a related technical field, with 0-2 years of experience.
- Systems Engineering Expertise: Demonstrated knowledge of software integration and testing, including requirements engineering, trade-off analysis, risk management, configuration management, and verification/validation.
- Regulatory Familiarity: Experience in a regulated environment and familiarity with FDA, ISO, and other relevant diagnostic product standards.
- Strategic Mindset: Interest in innovative technologies and an understanding of the in vitro diagnostics (IVD) competitive landscape.
Preferred Qualifications
- Experience: 2 years of relevant experience.
- Specialized Skills: Deep knowledge of software reliability, manufacturability, and usability.
- Leadership and Communication: Proven ability to establish authority and accountability within a team, along with strong collaboration and communication skills.
- Organizational Skills: Excellent organizational skills, with the ability to evaluate, prioritize, and manage multiple projects efficiently.
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Numbers & Facts
| Location | Tucson, AZ |
| Industry | Staffing/Employment Agencies |
| Company Size | 500 to 999 employees |
| Year Founded | 1990 |
About Company
For over two decades, Sharp Decisions has provided superior, award-winning service in strategic business and technology consulting services to government agencies at all levels, as well as domestic and global corporations. With subject matter expertise in Investment Banking, Finance, Healthcare, Media & Telecommunications, and Manufacturing, Sharp Decisions is well equipped to serve your needs.
Established in 1990 with headquarters in New York City, and locations in Princeton, Charlotte, Los Angeles, Phoenix, Europe and Canada, Sharp Decisions has been the technology backbone for a client portfolio that includes an array of well-known companies. As a Certified Woman-Owned Business Enterprise and approved vendor, Sharp Decisions offers a powerful, cost-effective advantage. We actively partner with other MBEs to add value and meet diversity program requirements.
Sharp Decisions is also committed to hiring and training post-9/11, tech-savvy U.S. armed forces veterans through our V.E.T.S.â„¢ (Vocation, Education and Training for Service members) Program, but we cannot do it alone. Companies like EmblemHealth, Freddie Mac and Experian have stepped up to bring aboard our highly qualified and skilled veterans. We need more companies like them to take a stand and bring our veterans aboard. Our clients have told us that our veterans are more effective than their college hires because two weeks on the job for them equates to 2-3 years of experience! Learn more at www.sharpdecisions.com/vetsprogram.
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