Jobs at Johnson & Johnson

Field-based Hematology Medical Science Liaison responsible for scientific engagement with KOLs, delivering non-promotional medical education, generating actionable insights, supporting investigator-initiated and company studies, and collaborating cross-functionally to inform medical strategy while maintaining compliance.

Lead cross-functional commercialization and sales operations initiatives for Shockwave Medical. Develop and oversee project plans, manage budgets and resources, identify and mitigate risks, report progress to leadership, drive post-launch analysis and continuous improvement, and implement program management best practices while mentoring team members.

Provide clinical case support and training for Shockwave IVL procedures across a North Bay territory. Support pre- and post-market clinical studies, manage investigator relationships, ensure timely data collection and compliance with GCP and regulatory requirements, and perform administrative duties including budgeting and travel. Participate in device training, procedure coverage, and clinical program execution.

Develop and maintain multi-threaded, multi-core real-time C++ software for a medical robotic platform. Debug timing, synchronization, and communication in real-time control loops; integrate software with hardware teams; write and run unit/integration/system tests for safety-critical software; participate in reviews, static analysis, and verification and traceability activities.

Lead technical lifecycle support for deployed surgical robotics systems: triage field issues, perform hands-on root cause analyses, implement mitigations, manage EOL activities, and drive cross-functional design changes to improve reliability and regulatory compliance.

Lead regulatory strategy and submissions for software, vision, endoscope, and integrated robotic medical devices. Manage premarket submissions (510(k), IDE, Q-Sub), lifecycle management, audits, and global registrations. Lead and develop a regulatory team, coordinate contractors and cross-functional partners, and apply expertise in software lifecycle, cybersecurity, and connected systems to obtain market access and support post‑market activities.

Lead regulatory strategy and execution for robotic instruments and accessories. Prepare and file FDA and global submissions (Q-submissions, IDE, De Novo, 510(k)), support design controls, risk management, regulatory evaluations, health authority interactions, and cross-functional teams to achieve product approvals and maintain compliance.

Author and manage Clinical Evaluation Reports (CERs) and supporting documents (CEPs, LSP/LSR, PMCF) to meet MEDDEV/MDR and other regulatory requirements. Conduct systematic literature searches, appraise clinical evidence, support regulatory submissions (CE Mark, PMA, IDE, 510(k)), liaise with cross-functional teams, manage timelines, and ensure compliance with SOPs and GCP. Provide clinical input for product development and post-market activities.

Lead and manage statistical programming for clinical studies and submissions, delivering validated analysis datasets, tables, listings, figures, and ad hoc outputs. Establish standards, oversee quality control and vendors, partner with cross-functional stakeholders, support regulatory submissions and audit readiness, and drive automation and process improvements while developing programming staff.

Support quality compliance and product release for Shockwave Medical devices by reviewing production and sterilization records, managing calibrations and incoming inspection, overseeing environmental monitoring and competency programs, supporting supplier controls, NCR/CAPA/SCAR metrics and audit activities, and driving QMS continuous improvement to maintain FDA, ISO and company standards.

Improve engineering productivity for Ottava surgical robotics software by building and optimizing CI/CD pipelines, managing builds/releases and automated merges, supporting AWS cloud environments with Terraform, maintaining Dockerized build/test environments, scripting in Python/Bash, and leading QNX OS image and software migration efforts.

Lead process development and NPI for catheter-based cardiovascular devices, collaborating with R&D, Quality, Regulatory, and Operations. Design, validate, and implement manufacturing processes, tooling, and test methods; support pilot production, supplier development, documentation, pFMEAs, IQ/OQ/PQ, statistical analysis, and product transfers ensuring regulatory and quality compliance.

Lead business development for Robotics & Digital Surgery: define strategy, scout and evaluate opportunities, build business cases, lead due diligence and deal execution, and partner across R&D, Finance, Marketing, and external stakeholders to integrate acquisitions and strategic partnerships.

Lead global and US commercialization for peripheral intravascular lithotripsy (IVL). Develop product positioning, value propositions, marketing campaigns, sales and physician education, forecasts, and customer engagement. Collaborate cross-functionally (R&D, regulatory, clinical, quality, sales, operations) and engage key opinion leaders. Conduct market research, analyze feedback, and drive product launches and market expansion.

Lead HR partnership for Robotics & Polyphonic business unit: design organization and talent strategies, drive culture and engagement, coach leaders, execute workforce and change management, and support organizational design and integrations to meet business goals.

Design and implement real-time control software and algorithms for next-generation medical robotic systems. Collaborate across multi-disciplinary teams to prototype, test, and validate robotic dynamics, human-robot interaction, and safety-critical controls. Develop test protocols, participate in design reviews, and support clinical and hardware integration activities.

Lead global and US marketing for peripheral Intravascular Lithotripsy (IVL), developing positioning, clinical/economic value propositions, campaigns, sales and physician education, market research, KOL engagement, demand forecasts, and cross‑functional commercialization to drive market penetration and launches.

Lead and grow a software engineering organization for the MONARCH robotic surgery product line. Set technical vision and roadmap, deliver high-quality, compliant medical device software (GUIs, firmware, robotics/controls, cybersecurity), manage budget and resources, and influence cross-functional stakeholders to support pre- and post-market needs.

Lead and develop a Development Engineering team for the OTTAVA surgical robotics platform. Drive NPD/NPI, design transfer, component and supplier development, manufacturability, process qualification, and regulatory-compliant commercialization. Partner cross-functionally to ensure robust, cost-effective, and manufacturable medical device solutions while managing resources, timelines, risks, and engineering deliverables.

Develops and delivers global professional education and curriculum for surgical robotics, collaborating with R&D, marketing, and external faculty. Delivers hands-on training for the OTTAVA system, integrates training technologies and LMS, tracks program metrics, manages budgets, and ensures regulatory and compliance adherence. Role requires stakeholder influence and up to 50% travel.