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 13485and 21 CFR 820practices (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