Systems Principal Architect

Zimmer Biomet; Minnesota; Presencial; USD 140.000 - 165.000; Jornada completa

Descripción de la vacante

Zimmer Biomet is seeking a Senior System Engineer to own and coordinate system requirements for the NeuroBlate product. You will work with hardware, software and clinical teams to ensure robust system design, risk analysis and traceability throughout development and post-market support.

Responsibilities include leading system and interface requirement reviews, coordinating V&V activities, and guiding engineering decisions, while maintaining currency with state-of-the-art technology and

Formación

• A bachelor’s degree in electrical, mechanical, computer engineering, computer science or related field is required.
• Eight years of engineering experience and three years in systems engineering are required.
• Experience writing requirements, architecture, risk analysis, design and workflow documents.
• Med Device experience strongly preferred.

Responsabilidades

• Owns, collaborates with cross-functional teams to manage requirements using Jama as the tool.
• Ensure compliance with FDA, ISO, IEC, CSA and EU regulations and guidance documents.
• Coordinate NeuroBlate software and system-level aspects, including traceability and analyses.
• Lead definitions and reviews of system and interfacing requirements and workflows.
• Guide stakeholders and translate needs into system requirements and VoC inputs.
• Support risk management activities and update the IFU for mitigators; assist V&V alignment.

Conocimientos

Interpersonal communication

Organizational skills

Root cause analysis

Fast learner

MRI environment exposure

Systems engineering mindset

Educación

Bachelor’s degree in Electrical/Mechanical/Computer Engineering or Computer Science

Graduate degree preferred

Descripción del empleo

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

The Systems Engineering role is focused on the integrated system consisting of disposables, hardware, and software. This role will be responsible for planning, developing, reviewing, coordinating, and documenting the systems components of the NeuroBlate system. This role involves close co-ordination between Hardware & software team from prototyping through testing. This includes the system requirements, system workflow, architecture, risk analysis(s), risk management report, system design, system traceability, and while coordinating with V&V engineers, addressing any system issues during V&V testing. As a senior member of the Engineering team, the System Engineer will also participate and when appropriate help guide sub-system requirements, risk analysis(s), design, and traceability. The Senior System Engineer will also contribute to any additions/changes to the IFU.

How You'll Create Impact

• Owns, Collaborates, and interfaces with the cross-functional team to ensure requirements management tool (Jama) is utilized per the training.
• Follows all applicable Monteris Quality System Standard Operating Procedures as well as various applicable FDA, ISO, IEC, CSA and EU regulations and Guidance Documents
• Co-ordinates & maintains the NeuroBlate software & system-level of the product, including traceability and impact analyses
• Leads the definition and formal reviews of the system & interfacing requirements and system workflow.
• Assists in the development of stakeholder needs such as the customer (VoC), marketing, product management, regulatory, and other system requirements (such as other VoB), which could include derived requirements of other requirements.
• Leads technical feasibility and risk burn-down projects, as appropriate
• Reviews subsystem requirements (e.g., software, hardware including disposables, and electrical) for sufficient coverage of system requirements and appropriate requirements definition.
• Participates when appropriate with the risk management team(s) in the definition and review of the risk analysis report(s), and the risk management report. Ensures that appropriate requirements are identified as mitigators to risks, and appropriate updates are made to the IFU for any risk mitigators.
• Coordinates as appropriate with the V&V team to clarify approach to V&V to meet the intent of the requirements, and resolve system issues found during testing
• Works with the clinical teams to resolve system level issues with product function, performance and compliance, including the system workflow
• Guides engineering team around technical approach with respect to post-market complaints, non-conforming materials, and other investigations, as appropriate
• Maintains a working knowledge of current state-of-the-art in technology and clinical practice through trainings, conferences, tradeshows, and in-field time.

What Makes You Stand Out

Skills/Abilities

• Excellent interpersonal communication skills with demonstrated ability to effectively interface with, and influence both internal and external team members
• Demonstrated strong organizational skills and attention to detail
• Root cause and problem solving
• Ability to learn quickly and understand complex technical concepts
• Has the ability to work in an MRI environment when required. Willing to travel to customer sites as required.
• System Engineering training, and/or recognized degree in Systems Engineering preferred

Your Background

Education/Experience

• A minimum of a bachelor’s degree in electrical engineering, mechanical engineering, computer engineering, computer science or other related field, graduate degree preferred
• A minimum of eight years of engineering experience and three years of systems engineering experience
• Experience writing requirements, architecture, risk analysis, design and workflow documents
• Experience in Med Device strongly preferred

Travel Expectations

Up to 20%

Salary Expectations

$140,000 - $165,000 USD

EOE/M/F/Vet/Disability