VP R&D — Design for Excellence (DfX) – Electrophysiology

Role Summary

The VP R&D — Design for Excellence (DfX) owns the enterprise DfX strategy, roadmap, standards and governance to ensure new and evolving products meet target quality, cost, manufacturability, serviceability, sustainability and time-to-market objectives. This leader builds and operationalizes maturity models, checklists and tooling, drives cross-functional alignment, enables continuous improvement, and leads a team of DfX specialists across product development and operations. Location: Irvine, California (preferred) with remote options in the US. Travel: Approximately 25% travel. Outcomes include designs that are manufacturable, reliable and scalable while meeting quality, safety and regulatory requirements, and cross-functional adoption of DfX methods across programs.

Responsibilities

• DfX Strategy, Governance and Operating model: Create and maintain DfX standards, stage-gate criteria checklists, templates/tools; Track KPIs and drive continuous improvements; Define the enterprise DfX vision, multi-year roadmap and value case aligned to business objectives (cost, quality, cycle time, sustainability); Translate strategy into prioritized programs, capability investments and KPIs; Identify emerging DfX trends, technologies and business risks and recommend strategic responses; Sponsor pilots to validate high-value DfX initiatives and scale successful approaches; Design and run the DfX governance framework (steering committees, stage-gate checkpoints, approval authorities, escalation paths); Establish design gates, formal DfX review cadence and sign-off criteria for product lifecycle stages; Define roles & responsibilities for DfX accountabilities across R&D, manufacturing, quality and supply chain; Implement audit and compliance processes for DfX adherence and continuous governance improvement.
• Program Oversight and Technical Leadership: Lead early approach to implement tolerance stackups, process capability, automation, test, supply; Lead portfolio-level DfX programs: set scope, milestones, resource plans and deliverables; Own technical outputs: enterprise DfX standards, design rules, checklists, maturity models, DFMEA/DVP&R best practices and verification criteria; Provide hands-on technical guidance on complex design-for-manufacturing, design-for-test, design-for-service, design-for-reliability and design-for-sustainability problems; Define and track DfX KPIs (e.g., cost reduction, first-pass yield, warranty rate, rework, time-to-volume); Oversee root-cause analysis and corrective actions for high-impact field failures and design escapes.
• Cross-functional Integration: Align manufacturing on early feasibility, tooling, process flow, PFMEA/control plans, and inspection strategy; Align Quality on risk methods, verification approach, and CTQs; Facilitate alignment between Product Development, Manufacturing, Quality, Procurement, Supply Chain, Regulatory and Service; Chair cross-functional DfX review panels and lead conflict resolution for competing tradeoffs (cost vs. reliability vs. time-to-market); Partner with suppliers to embed DfX expectations into early supplier involvement, design contracts and supplier scorecards; Ensure DfX considerations are integrated into roadmaps, product requirements and stage-gate criteria.
• Process, Tooling and Automation Readiness: Define process maps, line balance targets, test approach, equipment specs and validation needs; Assess automation options and guide feasibility / ROI; Define required digital tools and data flows (PLM, CAD/CAE rules, design rule checking, digital twin, simulation, automated checklist enforcement); Prioritize and sponsor tool rollouts, integration with enterprise systems and automation of DfX checks; Oversee creation and maintenance of libraries: part families, standard modules, design patterns and approved suppliers; Validate tooling readiness for scale, establish metrics for tool adoption and ROI.
• Capability Building and Change Management: Build DfX community of practice; Deploy enabling tools and drive adoption; Build a systematic capability plan: training programs, certifications, communities of practice and onboarding for DfX disciplines; Create learning assets: templates, playbooks, maturity assessments, and on-the-job coaching; Lead change-management activities to embed DfX practices across engineering and operations; Measure and report improvements in organizational DfX maturity.
• Leadership and Organization & Technical Development: Accountable for talent development, culture and capability; Recruit, mentor and develop a high-performing DfX team (discipline leads for manufacturability, reliability, testability, serviceability, sustainability); Set team objectives, performance metrics and career development plans; Drive matrix collaboration, delegate authority, and ensure appropriate staffing for DfX programs; Champion an inclusive culture that values technical excellence and continuous improvement; Support sustainable pipeline for the next generation of technical expertise; Build organizational capability to strengthen growth and development of employees and technical expertise; Conduct business activities in compliance with internal and external Health, Safety & Environmental, ethics and legal regulations and policies.

Qualifications

• Required: Minimum of 12 years of progressive leadership experience and in product development, manufacturing or related functions.
• Required: Deep technical knowledge across operations, project management, product or process development.
• Required: Strong systems thinking and ability to translate business goals into engineering standards and measurable outcomes.
• Required: Proven experience creating and implementing standards, maturity models and checklists.
• Required: Strong program and portfolio management skills: prioritization, resource planning, stage-gate discipline and metric-driven delivery.
• Required: Excellent influencing, stakeholder management and cross-functional facilitation skills at senior levels.
• Required: Solid change management experience (training design, adoption measurement, incentives).
• Required: Financial acumen for building value cases and tracking cost/benefit of DfX investments.
• Required: Ability to lead technical teams, hire top talent and foster continuous-improvement culture.
• Required: Effective communicator with executive presence and ability to present to C-level stakeholders and boards.
• Preferred: DfX domains: design-for-manufacturing (DFM), design-for-assembly (DFA), design-for-test (DFT), design-for-reliability (DFR), design-for-service (DFS), design-for-sustainability.
• Preferred: Hands-on familiarity with PLM, CAD/CAE tools, design rule checking, simulation, digital twin and lifecycle data management.
• Preferred: Experience with quality tools and methods (DFMEA, Root Cause Analysis, Six Sigma, statistical process control) and regulatory compliance where applicable.
• Preferred: Six Sigma Black Belt or equivalent, PMP or comparable program management certification, PLM/CAD tool certifications as relevant.

Education

• Bachelor’s degree required, Master’s degree preferred.