Synergy Bioscience is a consulting company serving the pharmaceutical and medical device industries. We have a need for a Senior Software Engineer to support one of our clients in the medical devices industry.
This position will primarily be concerned with translating users' needs, regulatory and technical standards into development specifications. Is accountable for developing clear, concise requirements for complex medical devices and their associated software applications. Defines the requirements and implementation of the software system structure and behavior. This position includes activities required in order to develop an assurance that the requirements and user needs have been met.
- Must have an Electrical background(EE degree) with Omron controls and mechanical disposables exp. Software Validation for controls
- Must be able to provide guidance for the evolution of these systems over time and across platforms.
- Must be focused on the processes, methods, and tools for the development of software-intensive systems in an economic and timely manner.
- Provides leadership for the functional group's development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
- Develops more complex use cases, identifying use, regulatory and stakeholder needs and translates these into requirements.
- Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
- Develops more complex regulatory software submission materials.
- Performs complex multi-layered data analysis and interpretation.
- Develops and executes validation protocols.
- Conceptualizes end-user validation activities. Works cross-functionally to identify customer test sites and evaluates test outcomes (application software).
- Coaches and educates software developers and software quality assurance engineers to understand complex end-user environments and industry practices.
- Provides mentoring to less experienced software system engineers.
- Collaborates with software architects and systems engineers to design and create optimal software solutions based on data analysis and existing business information.
- Maintains traceability of software user needs and requirements throughout project lifecycles.
- Guides the successful completion of design controls.
- Advocates for consistent processes across all projects and helps drive continuous improvement in these processes.
- Identifies hazards, develops mitigations and performs risk analysis. Maintains Risk Management file.
- Keeps updated on recent technical advances within the industry as well as evolving customer needs and applies this knowledge to products and processes.
- Develops new standard operating procedures, work instructions, and best practices as needed that have a significant impact on multiple disciplines.
Minimum 10 years experience.
- Real-life experience (start to finish) on large complex projects.
- Demonstrated leadership in driving requirements and project success, preferably using an Agile software development lifecycle.
- Experience with medical device software, real-time environments, distributed systems, device simulation, process control, embedded networking, human factors, and design controls, strongly preferred.
- Experience with SOA and web service architecture deployed and hosted software solutions, data management and database applications, human factors, and design controls, strongly preferred.
If you meet these requirements and are interested, please email your resume and your expected hourly rate.