| Hands-on software development leader needed to plan, develop and qualify software and firmware development and maintenance for Dynex’s instruments and PC applications in accordance with company Standard Operating Procedures (SOPs) and Quality System in a regulated (FDA) environment. Responsibilities: - Provide leadership to and manage Dynex’s software development team.
- Prioritize, track and communicate status of DYNEX software and firmware efforts under the general direction of the Engineering Management, Project Leaders and/or General Management.
- Improving existing software as needed. Respond to complaints, bug reports and questions regarding company software products and utilities. Investigate complaints and bug reports. Estimate the scope of investigation or proposed changes including qualification activities such as Verification and Validation. Qualify estimates with unknowns and potential conflicts.
- Ensure DYNEX SOPs are followed during development verification and validation of software.
- Maintain a state-of-the art knowledge of software and firmware technology, development tools and development methodologies.
- Liase frequently with Sales and Marketing in order to acquire and maintain detailed level of application knowledge. Communicate user requirements effectively to the development team.
- Communicate firmware requirements for electronic hardware to the electrical engineering group as appropriate.
- Inform and advise management and colleagues of project progress, complaint investigations and other information verbally and with detailed reports.
- Ensure accurate instructions are available for end-users.
- Maintain knowledge of FDA regulations regarding software verification and validation.
Qualifications: - Five years experience leading a software development team. Ability to motivate and mentor software developers.
- 10 years software development experience including: Dot Net, C Sharp, Visusal C++.
- Must have experience working with automated laboratory equipment.
- Ability to effectively manage software development projects within time and cost budgets.
- Knowledge of firmware development for a variety of embedded microprocessor systems.
- Knowledge of database design.
- Experience in software development for complex programmable automated systems.
- Experience in creating software requirements and specifications from marketing and customer requirements.
- Ability to identify and justify software/firmware/hardware tradeoffs.
- Ability to effectively interface with other internal (marketing, manufacturing, service) and external (customers, consultants) groups.
- Life Sciences, Medical, and/or laboratory instrumentation experience required. BS degree in engineering.
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