Work Flexibility: Hybrid or Onsite

We are seeking a System Architect to lead system-level design and technical direction for complex medical electronic systems with a strong embedded software and firmware component. In this role, you will define system and software architecture, guide cross-functional engineering teams, and ensure delivery of safe, compliant, and high-performing medical device platforms.

Development is conducted under global medical device standards and regulations, including IEC 60601, ISO 14971, and ISO 13485.

The successful candidate will design, develop, refine and evaluate electro-mechanical components, assemblies or subsystems for electro-mechanical medical devices and implants. You will use concurrent engineering and rapid prototyping techniques to reduce product time to market whilst adhering to project deadlines and product costs. You will plan and execute successful product development projects, occasionally leading and training team members on technical aspects of product commercialization.

What you will do:

Technical Responsibilities:

Lead or mentor technical team in design and development of components, sub-systems, and/or systems for medical devices.
Apply and mentor others on advanced engineering theories, principles, and concepts across various products within business unit.
Assess and integrate new technologies and capabilities (prototyping, testing, et.al.) for the organization.
Mentor and influence in correction of complex product design issues.
Generate and review the necessary documents with project teams. (requirements/design/architecture/bugs/test).
Development is conducted under global medical device standards and regulations, including IEC 60601, ISO 14971, and ISO 13485
Define and govern system and embedded software architecture
Translate product and user requirements into system, software, and subsystem specifications
Lead system and software architecture and design reviews
Navigate and influence the Intellectual landscape for filings and protection.
Translate user needs to design inputs/ specifications and produce system/architectural level layouts and platform designs.
Develop and influence a number of invention disclosures, patents or trade secrets.
Lead architecture of a complex system and guide design tradeoff decisions.

Business Responsibilities:

Possess an in-depth knowledge of the industry and competitive landscape.
Partner with customers, internal and external key opinion leaders to develop technical strategies that meet clinical needs.
Strategize and execute customer-facing activities like voice of customer and customer centric design across the business.
Collaborate on financial /business modeling and support business reviews to validate a technical approach.

Med Device Compliance:

Divisional expert with extensive experience applying industry standards in device development.
Act as independent reviewer and advisor for the creation or refinement of engineering documentation, such as the Design History file.
Lead the development of standards and regulations, working closely with functions within and across business.

General Responsibilities:

Lead cooperative efforts with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
Lead and support team members to create or improve procedures, policies, processes, systems, and technology requirements.
Develop and utilize tools to enhance the company’s product/process development or performance.
Mentor and grow technical talent within discipline/function.
Lead and support complex product development for cross functional teams, influencing multiple technical areas of expertise.
Hold team accountable to deliver high quality results with passion, energy and drive to meet business priorities.
Mentor, develop and influence across the business, intentionally building divisional relationships.
Identify and implement design and process solutions and ensure they are sustained over time.
Lead code reviews for projects/systems as independent reviewer applying design principals, coding standards and best practices.
Collaboratively review and update coding standards.

Technical Skills:

Programming Languages:

Lead system software implementation using programming skills applicable to Embedded Software.

Design and Development Skills:

Collaboratively lead strategies for integrated development environments (IDE) structures for projects.
Collaboratively lead strategies with tools for static/dynamic analysis, memory management, code coverage and techniques for analyzing software.
Collaboratively lead strategies for integration and deployment of processes used in complex embedded or electronic system development.

Software Process Skills:

Lead the adoption of Software Development Life Cycle process changes and best practices. Provide strategic planning and guidance for project based SDLC decisions.
Lead the adoption of Application Lifecycle Management /Traceability best practices and tools.
Lead teams in creating estimates for code implementation including time/resources for projects.
Regulatory and compliance standards applied to the SDLC (Software Development Life Cycle).

Preferred Skills / Engineering tools:

Demonstrated experience in system-level and embedded software architecture
Strong background in embedded firmware development (real-time systems, microcontrollers, or SoCs)
Experience defining software architecture in safety-critical or regulated environments
Experience developing medical devices under relevant standards (IEC 60601, ISO 14971, ISO 13485 or equivalent)
Experience delivering Class II or Class III medical devices to market
Experience with software lifecycle processes under IEC 62304
Experience supporting regulatory submissions and audits
Background in RF, power electronics, or energy delivery systems
Knowledge of cybersecurity requirements for connected medical devices

EDUCATION REQUIREMENTS

Bachelor’s degree in Electrical Engineering, Computer Engineering, Software Engineering, or related discipline
Minimum 10 years’ experience in complex embedded or electronic system development

Travel Percentage: 10%

Embedded Software Systems Engineer, R&D

Job Description