Responsible for supporting systems engineering project activities for medical device and drug delivery applications.
Responsibilities:
Supports the development of new products throughout the full product development lifecycle from initial concept to release to market of new medical devices; primarily class I and class II electro-mechanical devices.
Provides expertise in various Systems Engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, change management and reliability.
Plans systems engineering projects by identifying appropriate system development lifecycles.
Develops product development strategies for large or complex systems integrations.
Generates system architecture definitions, integrations, development viewpoints and models.
Manages the system architecture and relates it to the design throughout the lifecycle.
Defines requirements hierarchy and how it relates to verification and validation planning.
Performs functional system decompositions to solve complex design challenges.
Prepares detailed component and assembly drawings.
Participates in writing product and customer requirements, design and phase reviews, product and process risk assessments, root cause investigations, and corrective action planning.
Authors and executes test methods and protocols for design verification and validation.
Analyzes test data, interprets results, and formulates conclusions.
Maintains the Design History File (DHF) and ensures documents are complete, accurate, and current.
Contributes to developing systems engineering tools, processes, and systems.
Defines objectives and oversees task level output for projects with some supervision.
Contributes to solving open-ended problems and tasks.
Formulates and develops detailed project deliverables with management oversight.
Communicates technical risks and proposed solutions clearly with the customer.
Sources and interfaces with third party vendors.
Remains aware of industry trends.
Supports business development efforts by meeting with potential customers and providing input on engineering estimations.
Establishes trust and rapport with new clients with clear communication.
May act as mentor to engineering interns.
Travel will be required, as necessary (typically less than 5%).
Skills/Qualifications:
BS in Engineering or equivalent technical degree.
1+ years relevant experience.
Experience developing electro-mechanical medical devices, preferred.
Familiarity with system modeling tools and methodologies (e.g., UML, SysML), preferred.
Familiarity with working in both agile and waterfall methodologies, preferred.
Working knowledge of SolidWorks or other 3D CAD (Computer Aided Design) modeling software, preferred.
Familiarity with requirements management software (e.g., Jama, Polarion, Doors), desired.
Awareness of how to develop products for compliance with IEC 60601 for electrical safety and IEC 62304 for software development, preferred.
Awareness of how to develop products for compliance with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR, preferred.