Systems Principal Architect

Biomet Microfixation, LLC•Minnesota Lake, MN

1d•$140,000 - $165,000

About The Position

The Systems Engineering role focuses on the integrated NeuroBlate system, including disposables, hardware, and software. The position plans, develops, reviews, coordinates, and documents system components, working closely with hardware and software teams from prototyping through testing. Its scope includes system requirements and workflow, architecture, risk analysis and management reports, system design and traceability, and coordination with verification and validation (V&V) engineers to address system issues found during testing. As a senior member of the Engineering team, the role also helps guide subsystem requirements, risk analysis, design, and traceability when appropriate, and contributes to changes or additions to the IFU. The Systems Principal Architect coordinates across functions to support product development and maintenance, including requirements management, regulatory and quality-system compliance, technical feasibility and risk-reduction work, and collaboration with clinical, risk management, and V&V teams. The role may involve working in an MRI environment and travel to customer sites, with travel expectations of up to 20%.

Requirements

Bachelor’s degree in electrical engineering, mechanical engineering, computer engineering, computer science, or a related field.
At least eight years of engineering experience.
At least three years of systems engineering experience.
Experience writing requirements, architecture, risk analysis, design, and workflow documents.
Excellent interpersonal communication skills and demonstrated ability to interface with and influence internal and external team members.
Strong organizational skills and attention to detail.
Root-cause analysis and problem-solving ability.
Ability to learn quickly and understand complex technical concepts.
Ability to work in an MRI environment when required.
Willingness to travel to customer sites as required.

Nice To Haves

Graduate degree preferred.
Experience in medical devices strongly preferred.
Systems Engineering training and/or a recognized degree in Systems Engineering preferred.

Responsibilities

Own, collaborate on, and interface with cross-functional teams to ensure the Jama requirements management tool is used according to training.
Follow applicable Monteris Quality System Standard Operating Procedures and applicable FDA, ISO, IEC, CSA, and EU regulations and guidance documents.
Coordinate and maintain the NeuroBlate software and system level of the product, including traceability and impact analyses.
Lead definition and formal reviews of system and interfacing requirements and system workflow.
Assist in developing stakeholder needs, including customer (VoC), marketing, product management, regulatory, and other system requirements (such as VoB), including derived requirements where applicable.
Lead technical feasibility and risk burn-down projects as appropriate.
Review subsystem requirements, including software, hardware and disposables, and electrical requirements, for coverage of system requirements and appropriate definition.
Participate as appropriate with risk management teams in defining and reviewing risk analyses and risk management reports; ensure appropriate requirements are identified as risk mitigators and that the IFU is updated as needed.
Coordinate with the V&V team to clarify approaches that meet requirements and resolve system issues found during testing.
Work with clinical teams to resolve system-level issues related to product function, performance, compliance, and workflow.
Guide the engineering team on technical approaches to post-market complaints, non-conforming materials, and other investigations as appropriate.
Maintain working knowledge of current technology and clinical practice through training, conferences, trade shows, and time in the field.
Contribute to additions or changes to the IFU.
Travel to customer sites as required and work in an MRI environment when required.