Nikhil Karmarkar Email & Phone Number

QArma helps health-tech and med-tech businesses achieve better outcomes with better products compliantly and efficiently.Practice areas:Design Assurance | Software SDLC & Compliance | SPDF-Driven Cybersecurity | Risk Management | Standards Intelligence | Fractional Quality Management

San Mateo, California, Us

Design assurance manager and subject matter expert for hardware and software products in the wearable neurostimulation space.Managed a team of QA test engineers and mentored system engineers to appropriately scope and define design requirements for ease of translation into design outputs, test plans, and risk controls.Revamped design control and risk management processes to create an easy-to-follow roadmap for design history file creation and maintenance over a product's entire concept-to-sunset life cycle.Sourced, configured, and implemented an electronic requirements management tool (Jama Connect) to centralize design information and improve traceability and efficiency of review

San Francisco, Ca, Us

San Francisco, Ca, Us

As product quality process owner and SME for hardware NPD, I advise teams on design control, risk management, statistical methods, manufacturing transfer, and continuous improvement. Responsible for oversight of design quality of all hardware devices, in-house manufacturing tools, sustaining improvements, and firmware updates.

San Francisco, California, Us

As product quality lead for a cloud-based, AI-assisted cardiac radiology image viewing and annotation tool, I led design control, risk management, and process improvement activities to ensure the delivery of high-quality medical software to our global customer base.

Waltham, Ma, Us

As QA representative for NPD/NPI within the clinical and forensic toxicology product family, I advised development teams on requirements development, test design, documentation, design transfer, and critical-to-quality requirements, assisting with nonconformance and CAPA investigations, auditing DHFs and technical documents (plans, protocols and reports), and ironing out process issues at the interface with other departments as they arose.Led the migration of the training process from paper forms to an electronic system (Master Control). Configured, validated, and deployed the system, trained initial user base of managers and supervisors, and transferred ownership of system to training department.

Bad Homburg, Frankfurt, De

Managed design control documentation for multiple projects simultaneously. This included drafting and revising plans, protocols, reports, presentations, and procedures according to changing needs and compliance requirements.Led software validation for all tools used for product design and testing (data acquisition, bug trackers, configuration managers, static analyzers, development environments, simulators, debuggers, etc), whether the tools were developed internally or purchased.Supported IEC 60601 3rd Edition compliance effort by assessing compliance to SDLC and usability standards and closing the gaps through documentation and process verification.Participated in a corporate-sponsored cross-functional team responsible for unifying product development procedures across five sites (3 US-based, 2 international). Led enterprise-wide evaluation and selection of a new PLM package for the global R&D organization, then updated or drafted procedures to integrate the system into the newly-redesigned product development process.

Brainstormed, prototyped, refined and tested solutions to challenges in product design and engineering (materials, layout, deployment, spec trade-offs, etc.), test fixture setup, and shop organization. Explored and utilized unconventional approaches and adapted solutions from other disciplines to accomplish design goals.Anticipated design challenges by reviewing medical literature and researching existing products. Achieved a clear problem definition by storyboarding the use case and conferring with the client to identify and reconcile any unclear, confusing, or erroneous product requirements.Established raw material traceability procedures that tracked purchase orders and assigned lot numbers to incoming materials.

Master Of Business Administration (M.B.A.), Business Administration And Management, General

M.S., Medical Devices & Diagnostics Engineering

B.S., Bioengineering