At Alcon, the business problem is to develop and maintain medical device software that meets FDA/ISO regulations and improves patient outcomes, while ensuring timely and successful project delivery.
Requirements
- Medical device experience is required.
- Must have a solid understanding of FDA/ISO regulations for software development, including IEC 62304, and of Software Development Lifecycle Management (SDLC)
- Must have experience with C++, C, and Microsoft technology stack, with a clear understanding of object-oriented software design and large software architecture.
- Highly desired skills: WPF, QT, .NET, SQL.
- Experience with one or more software configuration management systems and related tools, such as: Confluence, Jenkins, Azure DevOps, Jira, Git, GitHub, TFS.
- Experience with Microsoft Visual Studios, ADO, or other integrated development environment (IDE) tool.
- Knowledge of networking and cybersecurity concepts are a plus.
Responsibilities
- Plans, conducts, and directs research and/or development that is highly complex in nature, necessitating the expert application of advanced knowledge in a particular field of specialization.
- Conducts process research, process development, and process upscaling for medical device products.
- Investigates and evaluates existing technology for design or processes updates, as needed, for medical device development.
- Supports engineering decision making by providing advice and recommendations to global project teams.
- Utilizes in-depth scientific and technical knowledge within clear framework.
- Troubleshoots complex anomalies and field issues for on-market products, evaluates supplier hardware changes for impact to software, defines recommended solutions to meet expectations, and incorporates changes according to defined processes and procedures, in line with industry standards and regulations.
- Collaborates closely with onshore and offshore development teams, Product Security, Technical Services, Field Service, Manufacturing, Regulatory, Quality, Marketing, and other internal organizations (as required) to assure software changes are aligned with company objectives and requirements.
Other
- Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
- The ability to fluently read, write, understand, and communicate in English.
- 7 Years of Relevant Experience
- Travel Requirements: 0-5%
- Relocation assistance: No
