New Product Introduction Manager

Role Summary

New Product Introduction Manager for MedTech capital equipment. Location: Santa Clara, California. Leads the introduction of product, material, equipment, and process changes in a regulated manufacturing environment, ensuring compliance, robust validation, and seamless integration into production. Partners with R&D, Manufacturing Engineering, Quality/Regulatory, Supply Chain, and Service to ensure safety, quality, and reliability for new configurations and ongoing changes.

Responsibilities

• Change Management & Build Readiness: Manage engineering changes (ECO/ECR) across mechanical, electrical, software, and consumable interfaces associated with capital equipment systems.
• Plan and oversee prototype, pilot, and production builds of capital equipment, coordinating cross-functional readiness across materials, equipment, tooling, documentation, and test systems.
• Own readiness reviews for changes impacting hardware, embedded firmware, manufacturing processes, and service procedures.
• Identify, escalate and problem-solve implementation risks.
• Cross-Functional Leadership: Lead cross-functional NPI teams including R&D, Manufacturing, Quality, Regulatory, Supplier Quality, Field Service, and Program Management.
• Ensure alignment on risk mitigation strategies, validation requirements, and manufacturing readiness criteria for every product or process change.
• Material, Equipment & Process Integration: Manage BOM updates and ensure accurate translation from EBOM to MBOM; support supplier qualification, material readiness, and process validation for new or modified components, subassemblies, and instrumentation; evaluate equipment, tooling, and automation requirements needed to support new product variants or process updates; ensure manufacturing lines meet throughput, quality, and compliance requirements.
• Quality, Compliance & Continuous Improvement: Partner with Quality and Regulatory teams to ensure compliance with FDA, ISO 13485, IEC 60601, and other relevant standards; support design risk assessments (dFMEA), process risk evaluations (pFMEA), and integration into change approval processes.
• Communication, Documentation & Reporting: Maintain and communicate NPI timelines, open issues, and cross-functional deliverables; provide executive-level reporting on program readiness, risks, mitigation actions, and production scale-up status; ensure all documentation (work instructions, test procedures, service manuals, acceptance criteria, traceability packages) is updated and released prior to deployment.

Qualifications

• Required: Bachelor's degree in Mechanical, Electrical, Biomedical, Systems, or Manufacturing Engineering or related field.
• Required: 5–10+ years in NPI, Manufacturing Engineering, or Technical Program Management for complex electromechanical products such as MedTech Capital Equipment, Robotics, Aerospace or Automotive.
• Required: Experience with manufacturing quality systems in regulated environments.
• Required: Demonstrated success running prototype/pilot builds, validation phases, and manufacturing transitions for complex electromechanical systems.
• Required: Strong understanding of BOM management, ECO/ECR processes, verification/validation planning, and change control discipline.
• Required: Ability to lead cross-functional teams and manage multiple complex programs simultaneously.
• Preferred: Experience with electromechanical/robotic capital equipment, surgical systems, diagnostic platforms, imaging equipment or other MedTech products.
• Preferred: Familiarity with IQ/OQ/PQ methodologies and equipment qualification best practices.
• Preferred: Experience working in regulated environments under FDA 21 CFR 820, ISO 13485
• Preferred: Knowledge of PLM systems (Agile, Arena, Windchill)
• Preferred: Background integrating firmware/software-controlled hardware in regulated manufacturing.
• Preferred: Lean/Six Sigma certification or experience with process capability improvement.
• Preferred: Strong communicator capable of influencing teams at all organizational levels.
• Preferred: Able to translate complex technical challenges into structured plans and actions.
• Preferred: Highly organized with strong judgment in balancing speed, compliance, and risk mitigation.
• Preferred: Comfortable in an environment that requires decisive action, technical rigor, and cross-functional alignment.

Additional Requirements

• This position will require up to 10% of domestic travel.
• The attendance policy for this position is Fully Onsite.