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Director of Operations
Director of OperationsELIXIR MD Inc • Irvine, CA, United States
Director of Operations

Director of Operations

ELIXIR MD Inc • Irvine, CA, United States
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Director of Operations

Location :  Irvine, CA

Company :  ELIXIR MD Inc.

Industry : Medical Devices (Global Aesthetic & Surgical Markets)

About Us

ELIXIR MD™ Inc. is a fast-growing, founder-led medical device company disrupting the aesthetics and plastic surgery space with innovations like  ELIXIR MD™  and  EVA 3D™ . We’ve bootstrapped to multimillion-dollar revenue by obsessing over execution, creativity, and customer outcomes—and we’re now hiring a  Director of Operations  to build the infrastructure for our next stage of scale.

The Role : Director of Operations

You’ll partner directly with the Founder and leadership team to tighten internal systems, scale operations, and ensure all moving parts—from sales and finance to fulfillment, clinical, and compliance—run like clockwork. A key part of your remit is to  own Product Lifecycle Management (PLM)  across the company.

What You’ll Do

PLM Ownership (Core Mandate)

  • Select, implement, and own the PLM platform  (e.g., Arena / Propel / Agile / Centric) with clean integrations to QMS, ERP / finance, and CRM.
  • Establish  part numbering, item masters, and BOM structures  (EBOM / MBOM alignment) with revision control and effectivity dates.
  • Stand up  ECR / ECO change control  and cross-functional review workflows (R&D, Clinical, Quality, Ops, Marketing).
  • Drive  Design Control traceability  (user needs → design inputs / outputs → V&V) and maintain links to  DHF / DMR / DHR  artifacts.
  • Govern  labeling, UDI / serialization data, and configuration management  within PLM.
  • Run  NPI stage-gate  (concept → feasibility → development → verification / validation → launch → sustaining) with clear exit criteria and RASCI.
  • Implement  document control  and training acknowledgment workflows (read-and-understand, quizzes) for SOPs, WIs, and work instructions.
  • Create  product release checklists  (regulatory, IFUs, packaging / artwork, service docs, training assets) and coordinate cross-team readiness.

Operations & Business Systems

  • Implement systems and tools that streamline operations across departments (sales, clinical, logistics, customer support).
  • Oversee  financial & sales reporting , ensuring real-time data drives decisions.
  • Manage internal company finances :   budgeting, forecasting, expenses, reporting .
  • Supervise back-office operations, including  payroll, financials, and taxes .
  • Lead  HR operations : onboarding, benefits, internal policies, and performance frameworks.
  • Manage  commercial insurance, compliance documentation, contracts , and professional-services partners.
  • Oversee  outsourced accounting, legal, and payroll  partners; manage in-house support staff.
  • Develop and optimize processes across  fulfillment, device tracking & RMA, clinical training coordination, and partner success .
  • Own  company policies, internal communications, and knowledge management .
  • Coordinate with  Marketing & Production  to align timelines, assets, and product launch readiness.
  • Support  launch operations  for new clinics and manage  device shipment logistics .

    • Who You Are

  • 7+ years  in operations within high-growth startups, medtech / healthcare, or B2B product companies.
  • Hands-on PLM experience : system ownership, ECR / ECO workflows, BOMs, document control, and NPI stage-gates.
  • Familiar with  ISO 13485  and  21 CFR 820  practices (design control, DHF / DMR / DHR, CAPA linkages), in partnership with Quality.
  • Strong grasp of  finance and HR operations ; adept with dashboards, automation, and cross-system integrations (PLM / QMS / ERP / CRM).
  • Resourceful, entrepreneurial, and relentless about execution.
  • Based in  Orange County  (on-site).

    • Why Join ELIXIR MD™ Inc.

  • Founder’s Seat at the Table :  Work directly with the CEO and leadership team.
  • High Impact :  Architect the operating and PLM backbone of a category-defining company.
  • Creative Freedom :  Autonomy to build systems, workflows, and teams the right way.
  • Rapid Growth :  Equity, performance bonuses, and clear career growth in a scaling business.
  • Opportunity to be a key part of a fast-scaling medical device company.
  • Direct impact on global adoption of transformative technology for plastic surgeons.
  • Collaborative, entrepreneurial culture that values execution and results.
  • Medical Equipment Manufacturing

    • Compensation & Benefits

  • Competitive base salary
  • Generous Bonus structure + Equity
  • Comprehensive benefits
  • Paid Time Off (Vacation, Sick, Holidays)
  • 401(k) Retirement Plan
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