Johnson & Johnson

Engineering Manager

• Lead, mentor, and develop a team of design engineers, CAD designers/technicians, and documentation specialists (PLM)
• Design for Reliability (DfR) practices, including durability analysis, fatigue assessment, wear modeling, and lifetime testing strategies.
• Design for Manufacturability and Assembly (DfM/DfA) efforts to ensure scalable, repeatable, and cost‑effective production.
• Own and drive mechanical system requirements, ensuring alignment with system‑level requirements, user needs, performance targets, and regulatory constraints
• Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.
• Partner with manufacturing engineering to optimize component sourcing, assembly processes, tolerances, and inspection methods.
• Oversee and guide tolerance stack‑up analysis, ensuring precision requirements are met for functional performance.
• Ensure appropriate use of analytical and simulation tools (FEA, thermal, kinematic modeling) to support design decisions and risk mitigation.
• Maintain mechanical design documentation, calculations, and analysis outputs suitable for design reviews, audits, and regulatory submissions.
• Collaborate closely with electrical, system, and software teams to ensure seamless mechanical‑electrical‑firmware integration.
• Define and review mechanical design concepts, trade studies, and architecture decisions to balance performance, reliability, manufacturability, cost, and serviceability.
• Participate in and contribute to risk management activities, including DFMEA and system‑level hazard analysis.
• Ensure mechanical risk controls are correctly implemented, verified, and validated.
• Review test results, investigate failures, and drive corrective actions for mechanical issues identified during development, validation, or field use.
• Ensure mechanical designs comply with applicable regulatory and quality standards (e.g., FDA, ISO 13485, IEC 60601 standards, material compliance).
• Partner with quality and regulatory teams to support design controls, audits, and regulatory submissions.
• Ensure documentation, design outputs, and change management comply with quality system requirements.
• Lead, mentor, and develop a team of design engineers, CAD designers, and documentation specialists (PLM) fostering technical excellence, accountability, and collaboration.
• Assign work, set technical direction, conduct design reviews, and provide coaching to support professional growth.
• Plan and execute engineering deliverables in alignment with program schedules and business objectives.
• Prepare annual and multi-year budget and resource plans aligned with business strategy
• Drive continuous improvement of engineering processes, CAD tools, and best practices.
• Stay current with advancements in mechanisms/mechatronics, precision gearing, materials, and manufacturing methods.
• Encourage innovation while maintaining disciplined engineering rigor, reliability, and compliance.

R&D Engineering Manager

• Lead, mentor, and develop a team of design engineers, CAD designers/technicians, and documentation specialists (PLM)
• Design for Reliability (DfR) practices, including durability analysis, fatigue assessment, wear modeling, and lifetime testing strategies.
• Design for Manufacturability and Assembly (DfM/DfA) efforts to ensure scalable, repeatable, and cost‑effective production.
• Own and drive mechanical system requirements, ensuring alignment with system‑level requirements, user needs, performance targets, and regulatory constraints
• Identify critical paths during product development, address bottlenecks and risks and facilitate problem solving across R&D teams.
• Partner with manufacturing engineering to optimize component sourcing, assembly processes, tolerances, and inspection methods.
• Oversee and guide tolerance stack‑up analysis, ensuring precision requirements are met for functional performance.
• Ensure appropriate use of analytical and simulation tools (FEA, thermal, kinematic modeling) to support design decisions and risk mitigation.
• Maintain mechanical design documentation, calculations, and analysis outputs suitable for design reviews, audits, and regulatory submissions.
• Collaborate closely with electrical, system, and software teams to ensure seamless mechanical‑electrical‑firmware integration.
• Define and review mechanical design concepts, trade studies, and architecture decisions to balance performance, reliability, manufacturability, cost, and serviceability.
• Participate in and contribute to risk management activities, including DFMEA and system‑level hazard analysis.
• Ensure mechanical risk controls are correctly implemented, verified, and validated.
• Review test results, investigate failures, and drive corrective actions for mechanical issues identified during development, validation, or field use.
• Ensure mechanical designs comply with applicable regulatory and quality standards (e.g., FDA, ISO 13485, IEC 60601 standards, material compliance).
• Partner with quality and regulatory teams to support design controls, audits, and regulatory submissions.
• Ensure documentation, design outputs, and change management comply with quality system requirements.
• Lead, mentor, and develop a team of design engineers, CAD designers, and documentation specialists (PLM) fostering technical excellence, accountability, and collaboration.
• Assign work, set technical direction, conduct design reviews, and provide coaching to support professional growth.
• Plan and execute engineering deliverables in alignment with program schedules and business objectives.
• Prepare annual and multi-year budget and resource plans aligned with business strategy
• Drive continuous improvement of engineering processes, CAD tools, and best practices.
• Stay current with advancements in mechanisms/mechatronics, precision gearing, materials, and manufacturing methods.
• Encourage innovation while maintaining disciplined engineering rigor, reliability, and compliance.
• Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Support project resource and schedule planning.

Strategy

• Lead the end-to-end commercial strategy, performance, and competitiveness of the APAC Autoantibody portfolio
• Full lifecycle responsibility from pipeline through launch and growth
• Enterprise-level strategic planning and execution
• Investment prioritization and ROI optimization
• Leadership of cross-functional regional ecosystem and OpCo alignment
• Influence on both regional execution and global strategic direction

Director, Regional Commercial Strategy, Autoantibody Disease

• Lead the commercial strategy, performance, competitiveness, and growth of the APAC ImmunoDerm portfolio.
• Drive portfolio growth, launch excellence, market leadership, and pipeline readiness across APAC.
• Align and influence APAC Operating Companies.
• Establish portfolio KPIs and performance dashboards.

Director, Regional Commercial Strategy, ImmunoDerm

Compliance

• Draft cover letters and support the preparation of various applications (ie: IND, CTA, MAA/NDA and eCTD), and procedures for Regulatory Agency submissions.
• For CTA/INDs – Ensure protocols are in alignment with regulatory requirements and provide advice on required documents and submission strategies in preparation for those filings.
• For Marketing Authorization Applications (NDA, MAA or other major HA submissions): Provide regulatory support throughout the registration process.
• Advise team on required documents and submission strategies in preparation of NDA, MAA (and other global filings) as assigned (in collaboration with LOCs as appropriate).
• Assist with timely NDA, MAA (other) availability, ensure that all document components are in place on time, identify and track critical path activities.
• Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, other).
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.
• Assist in the preparation of meetings with Regulatory Agencies.
• Coordinate, contribute to development, and review the content of responses to queries from HAs to ensure high quality and timely responses.
• May include other activities as delegated by the RRL/GRL.
• Liaise with LOCs, track dates of submissions/responses to queries in a timely manner.
• Acts as back up contact/representative on specific multi-discipline teams, or with regulatory agencies as needed.
• May be responsible for organizing and leading meetings.
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints.
• Supports GRL(GRT) by driving high project management planning of global submissions or Health authority interactions and additional major regulatory milestones.
• Participate in global regulatory team meetings as appropriate.
• Assist in strategy development by researching regulatory and medical information in preparing submissions to Global Health Authorities (HAs).
• Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned.
• Partner with regulatory colleagues to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences, and disease area-specific issues.
• May assist in the development and improvement of regulatory processes.

Manager, Global Regulatory Scientist – Regulatory Affairs

• Draft cover letters and support the preparation of various applications ie: IND, CTA, MAA/NDA and eCTD), and procedures for Regulatory Agency submissions
• Ensure protocols are in alignment with regulatory requirements and provide advise on required documents and submission strategies in preparation for those filings.
• Provide regulatory support throughout registration process
• Advise team on required documents and submission strategies in preparation of NDA, MAA as assigned (in collaboration with LOCs as appropriate)
• Assist with timely NDA, MAA availability, ensure that all document components are in place on time, identify and track critical path activities
• Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, other)
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans
• Assist in the preparation of meetings with Regulatory Agencies.
• Coordinate, contribute to development, and review the content of responses to queries from HAs to ensure high quality and timely responses.
• Act as back up contact/representative on specific multi-discipline teams, or with regulatory agencies as needed.
• May be responsible for organizing and leading meetings.
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints.
• Support GRL(GRT) by driving high project management planning of global submissions or Health authority interactions and additional major regulatory milestones.
• Participate in global regulatory team meetings as appropriate
• Assist in strategy development by researching regulatory and medical information in preparing submissions to Global Health Authorities (HAs).

Technical Product Manager

• Manage the Finance applications running on the Treasury platforms (SAP ECC/S4, JAVA and SWIFT technology) and lead delivery for the Treasury squad.
• Responsible for the vision and priorities of projects and enhancements on those platforms and all associated feature/function/capabilities delivered in support of our Global Treasury Services.
• Close collaboration with key stakeholders across all levels of our organization in the planning, implementation, deployment of programs and projects.
• Responsible for the Technology strategy development for Treasury.
• Provide oversight and direction for multiple initiatives, driving global strategy development as well as the planning, execution/implementation and operational aspects of all areas supporting a wide variety of business and Technology initiatives.
• Manage relationships with Treasury including external interactions / relationships with key Technology application suppliers.

Technical Product Manager – Treasury

QA Engineer

• Provide operational leadership for quality assurance and regulatory affairs supporting the Hong Kong market
• Ensure regulatory compliance and effective quality management system execution
• Safeguard patient safety and manage quality and regulatory risk
• Partner with local market stakeholders, regional leadership, and Global QARA teams
• Lead and manage QARA activities for product registrations and lifecycle management
• Coordinate regulatory submissions and responses to health authority inquiries
• Monitor regulatory, quality, and enforcement changes applicable to Hong Kong
• Support regulatory inspections, quality audits, and compliance assessments

Manager, QARA

Customer Support

• Drive excellence across international operations by owning end-to-end process standardisation, governance, performance management, and continuous improvement
• Partner with Supply Chain, IT, Commercial, Finance, international and local market CS leaders, and GS teams to align systems, data, and ways of working
• Ensure scalable, compliant, and integrated service delivery across markets, supported by strong KPI governance, insight-led reporting, and effective oversight of GS performance and execution
• Own and standardise end-to-end Customer Service processes, defining, documenting, and governing standardised frameworks
• Lead process optimisation and continuous improvement initiatives, identifying inefficiencies and pain points in core processes

Customer Service Excellence Lead

Sales

• Develop and execute quarterly business plans that achieve capital system sales, procedure growth, and disposable revenue targets within the assigned territory.
• Build and maintain a strategic territory plan, including account segmentation, funnel management, forecast updates, and launch prioritization.
• Develop relationships with physicians, nurses, administrators, value analysis stakeholders, and economic buyers to understand customer needs, decision processes, and funding pathways.
• Lead product, technical, and clinical discussions and demonstrations to support evaluation, conversion, and adoption of Monarch Urology.
• Present value propositions and collaborate with sales leadership on pricing, program terms, and commercial strategies that support mutually beneficial customer outcomes.
• Coordinate post-sale installation readiness, training, launch support, and adoption plans in partnership with Clinical Representatives, service partners, and internal stakeholders.
• Support customers in achieving clinical, operational, and economic goals while driving long-term utilization and customer satisfaction.
• Partner closely with the Regional Business Director and Clinical Representative to execute referral education, account development, and utilization growth strategies.
• Maintain expert-level knowledge of Monarch Urology products, kidney stone treatment workflows, customer economics, and competitive market trends.
• Operate in full compliance with company policies, healthcare industry regulations, and all applicable quality requirements.

Area Sales Leader

Area Sales Leader – Urology

Analyst

• coordinate and optimize outbound transportation operations across assigned distribution centers, ensuring reliable, compliant, and cost-effective parcel transportation services.
• collaborate closely with transportation providers, distribution center operations, and supply chain partners to drive operational excellence, continuous improvement, and customer service performance.
• ensure reliable day-to-day transportation execution with a focus on speed, quality, compliance, and customer service.
• monitor transportation performance and implement corrective actions with carriers and supply chain partners when required.
• lead Carrier Operational Performance Reviews to ensure service level achievement, drive corrective actions, and identify optimization opportunities.
• identify opportunities for business process harmonization and continuous improvement across transportation operations.
• provide analytical and project management support for operational and financial improvement initiatives, including carrier changes, lane implementations, transportation mode shifts, and order profile optimization.
• lead shipment complaint and claims management processes while driving systemic improvements to eliminate recurring defects and enhance transportation performance.

Outbound Transportation Analyst

Representative

• Provide in-case procedural support and technical expertise to physicians, nurses, and staff using Monarch Urology in hospital and ambulatory surgery center environments.
• Help create and maintain strong customer relationships through consistent clinical support, training, education, and responsive service.
• Support account development activities that build clinical confidence, increase user competence, and drive system and disposable utilization.
• Assist with product and clinical demonstrations, launch planning, training events, and customer education initiatives.
• Identify and act on educational opportunities that improve customer proficiency, procedural efficiency, and clinical adoption.
• Partner with the Area Sales Leader and Regional Business Director to support business objectives, account plans, and referral development activities.
• Serve as a liaison between customers and internal teams for questions, issue escalation, peer-to-peer review needs, and timely reporting of complaints or technical concerns.
• Develop and maintain expert-level product knowledge and a strong understanding of kidney stone treatment workflows, customer needs, and procedural best practices.
• Deliver a high standard of professionalism, service, and compliance in all customer interactions.
• Lead and support sales activities at the account level ensuring products are purchased and in-stock to support procedures and growth of the account.