Systems Developer, Senior

The Opportunity 

The systems developer is a key member of a multi-disciplinary team that seeks to use systems-level thinking to direct and contribute to product development. You’ll have the unique opportunity to become a product expert where you’ll learn how the many subsystems work to create a state-of-the-art medical device. We are looking for someone who is eager to dig in, learn and actively contribute to our team. 

What You’ll Do 

• Become a subject matter expert on the design, function, and performance of Synaptive’s surgical product lines 
• Contribute to system level design of new product and product improvements 
• Generate and document system requirements and detailed specifications 
• Plan, coordinate and execute risk management activities (e.g., Hazard Analysis) and human factors testing 
• Assemble and test of prototype systems  
• Assist with transfer to manufacturing activities of new and sustaining product lines (knowledge transfer, documentation transfer, etc.) 
• Lead and participate in design reviews, phase reviews, post market trend reviews 
• Work closely with other team members and the QA team to ensure quality and punctual development 
• Manage and co-ordinate third-party standards testing (e.g. biocompatibility, safety) 
• Provide guidance on use and application of standards applicable to design projects  
• Liaison with suppliers, generate RFQs and SOW, as necessary 
• Support the regulatory team in the creation and response to regulatory filings 

What You’ll Need 

• Bachelor’s degree in Systems Engineering or equivalent 
• 5+ years of experience in product development 
• 3+ years of experience in a regulated environment 

It’d Be Amazing If You Had 

• Knowledge of and experience with the following standards: IEC 60601-1, IEC 60601-1-2, ISO 13485, ISO 14971, IEC 62366, IEC 62304 
• Experience in the design, development, and testing of medical devices 
• Experience in electrical design and development