Noah Goldstein Email & Phone Number

California, United States

New Brunswick, NJ, US

• Own key subsystem of J&J’s soft tissue surgical robotics platform. Responsible for getting from prototype stage through commercialization.
• Manage partnership with external co-development partner. Drive full breadth of activities from strategic planning & alignment with company executives to day-to-day engineering and manufacturing tasks.
• Drive alignment across the program through ownership of the full program’s Objective & Key Results (OKRs).

Cambridge, MA, US

• Directed development of a drug delivery system consisting of a software controlled needle-free injector and a single-use cartridge (Class II medical device).
• Led project management team responsible for coordination between mechanical/electrical/software engineering, manufacturing, marketing, QA/RA.
• Owned high-level company timeline and managed high-level strategic objectives for multiple simultaneous device development projects from R&D through manufacturing and commercialization.
• Served as the Alliance Manager for a key pharmaceutical customer based in Europe.
• Managed the full design control process in compliance with Portal’s ISO 13485 certified quality system, including specification/requirements generation, R&D, risk management in accordance with ISO 14971.

Cambridge, MA, US

• Guided alignment within internal cross-functional teams & externally with Portal’s corporate pharmaceutical customers.
• Developed risk-based design verification plan. DV plan included standards testing to IEC 60601 Medical Electrical Equipment, ISO 21649 Needle-free Injectors, ISO 10993 Biocompatibility, and FDA Guidance Documents.
• Owned design verification activities, including fixture development, test method validation, test execution, statistical analysis, and all associated documentation.

Cambridge, MA, US

• Oversaw vendor relationship with critical supplier of specialized motors and motion control hardware. Managed design, testing, strategy, and procurement.
• Trained and mentored junior team members in electrical and mechanical engineering.
• Oversaw a broad range of company operations, including laboratories, IT and facilities.

Cambridge, MA, US

• Designed variety of PCBs used in the commercial device. PCB functions included UI, power delivery and motion control.
• Characterized & analyzed DC motors, controllers and associated equipment.
• Supported successful ISO 13485 certification and audits.

Cambridge, MA, US

• Led development of LabVIEW based dynamometer-like system, with significant contributions to electro-mechanical software integration, UI, motion control and high-power PCB design using Altium Designer.
• Designed, tested, and managed technical support of key hardware safety circuit for first-in-human trial.

Cambridge, MA, US

• Managed electro-mechanical laboratory, test design, execution & reporting, and organization/calibration of critical equipment.
• Designed capacitance discharge circuit for high-voltage application.
• Developed jet stream analysis program in Python to markedly accelerate key research & development.

Westwood, Massachusetts, US

• Tracked/analyzed major power outages and created reports for senior management.
• Coordinated power grid automation project across company departments.
• Led a power outage analysis project that was presented to company President/VPs upon completion.

Master Of Business Administration (Mba) With Honors

Bachelor Of Science In Electrical Engineering With Minor In Business Administration