https://www.crosbydevelopment.com/

I was the technical program manager for the 30+ person Software Systems and Safety Engineering team, responsible for software system architecture, software requirements definition, safety analyses, and testing strategy + definition + execution.Key Responsibilities & Achievements:● Drove execution of the software department's Safety Case, ensured that safety-critical deliverables were consistently delivered along Aurora's product roadmap. Hit all key externally-reported Product Readiness OKRs: 44% (Q1) -> 65% (Q2) -> 84% (Q3), which were derived via the Safety Case.● Drove a cross functional team (core autonomy, systems eng., risk) to produce 1000s of simulation-based tests to explore system performance during the presence of subsystem limitations/deficiencies. Frequently described as the highest value testing to the organization.

I was the technical program manager for the Organizational Safety team, which was a 30+ person team responsible for organization-wide safety policies, safety regulatory initiatives, risk-management, operational safety, and safety concern reporting & investigation.Key Responsibilities & Achievements:● Restructured the company-wide program to drive NVO Road Safety Case (a multi-year initiative) efforts forward, uniting technical engineering planning efforts and safety case deliverables under a singular, JIRA-based management framework● Product Owner for internal Safety Case Tooling initiatives - successfully defined, resourced, and deployed two internal software tools, improving executive-level visibility and execution efficiency● Presented Aurora’s Safety Case approach at Lifesavers 2023 (2000+ road safety advocates): How Safe Is Safe Enough (Part 1)? Conveying the ADS Safety Case From A Manufacturer's Perspective● Created and operationalized NVO Safety Case Closure process based on ASPICE and CMMI standards

I was a lead systems engineer for R&D/NPI projects within the S+N robotics product portfolio. I also supported early research (pre R&D / NPI) endeavors and product remediation + post-market activities.Key Responsibilities & Achievements:● Launched RI.HIP NAV on CORI in US - expanded platform from solely knee to hip surgical applications. Served as the lead systems engineer on the project and was responsible for the product development lifecycle.● Promoted CORI cementless implant compatibility into R&D by establishing and proving early-stage validation criteria via a series of benchtop & surgeon-user testing + tooling qualification activities.● Continuously improved CORI and NAVIO products and documentation to maintain state-of-the-art expectations, which streamlined a number of downstream activities: parallel development projects, regulatory filings for market expansion, quality audits, etc.

Core member of a scrappy team who took an idea conceived in an entrepreneurship class into a fully functioning prototype with a completed design for manufacturability. Ultimately shelved the business, but learned countless lessons along the way!Key Achievements:● Developed idea, business model, and proof-of-concept prototype for our flagship product: a heated foam roller● Co-lead for all product and engineering decisions - responsible for design, testing, and construction of initial prototype & served as key advisor on the design for manufacturability

I was an EUMDR remediation team lead for surgical components in the Stealth Station S7 and S8 product lines.Key Achievements:● Completed remediation activities for high-priority devices ahead of May 2020 deadlines - preventing potential sales impacts● Evaluated entire product history files for gaps and drove necessary design changes to closure through an accelerated development lifecycle. Functional design, packaging, and labeling changes were necessary to achieve meet EUMDR expectations.● Coordinated efforts across a team of ~10 engineers and created templates and streamlined processes to improve program execution efficiency. Requirements review templates and best practices within labeling and packaging were later incorporated into NPI processes.

I was a product and manufacturing remediation team lead for the CODA cardiovascular balloon catheter line in response to an FDA warning letterKey Achievements:● Completed product remediation efforts using a complaint-driven, risk-based approach. Delivered updated design lifecycle documentation including Use Specifications, Clinical Effects Analyses, Design Inputs, Verification & Validation Activities, and (d, p, u)FMEAs● Revalidated manufacturing processes to modified Quality Management expectations through the creation and execution of qualification reports (Tooling Qualifications, Software Qualifications, Operational Qualifications, Performance Qualifications)

I was part of an 8 person startup team developing a low-cost electroencephalogram and integrated software. I had direct involvement with R&D, production, business development, documentation, and research opportunities.Key Responsibilities & Achievements:● Administered WAVi EEG scans to clients and gave product demos to potential customers● Improved low-volume manufacturing processes to prepare for ISO certifications. Implemented barcode-based component tracking for quality and inventory management.● Evaluated research opportunities by analyzing comparable experimentation and published articles in the related field, and drafted IRBs for prospective experiments● Completed materials testing for a failure-prone component

Member of the first mechanical engineering intern cohort at NevroKey Responsibilities & Achievements:● Produced and updated 3D models and part drawings using SolidWorks software● Designed and executed testing for OR Cables, Implantable Pulse Generators, and Paddle Leads● Implemented in-house 3D printing capabilities for rapid prototyping● Produced and compiled FDA documentation including part specifications, test specifications, and design history files● Designed, fabricated, and implemented three systems to improve testing, manufacturing, and verification activities for Nevro (IPG – Charging Pad interface, Lead Cable Identification device, Paddle Lead Bend device)

• Ground-up understanding of engineering concepts implemented in ski lifts including mechanical design and safety-monitoring systems• Worked on and operated detachable and fixed lifts• Calculated pull load values and factors of safety for splicing procedures• Performed non-destructive analysis (NDT) on lift elements including, but not limited to chair arms, gears, and engine components