Head of R&D, Energy Based Device (Architecture)

About Us

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

A Brief Overview

As Head of R&D Energy Based Device (EBD) you will be responsible for the R&D design, development and execution of all Merz Ax Energy Based Device (EBD) projects and for ensuring they are run to applicable regulations and to time and budget. You will also be responsible for the North America R&D Innovation Center EBD laboratory. You will provide leadership and direction to the R&D EBD team and the projects. You will report directly to the Chief Scientific Officer and will sit on the R&D Leadership Team.

 What you will do

• Department Management:
  • Leadership and management of the R&D EBD team, including resource planning, recruitment, team development and performance management.
  • Setting specific EBD department functional goals in line with the overarching R&D priorities.
  • Establishing and maintaining constructive communication with other R&D functional heads.
• Product Development:
  • Oversee design, prototyping, testing, and validation of new features in EBD projects.
  • Ensure timely and cost-effective development of products that meet clinical and market needs
• EBD Laboratory:
  • Oversee the EBD laboratory ensuring it is run to the appropriate standards and that all SOPs, test plans, draft/final reports are in place to support product clearance/approvals.
• R&D EBD Projects:
  • Franchise Expert for EBD projects.
  • Providing appropriately qualified trained staff to meet project needs.
  • Ensuring Global Development Plans are in place for all EBD projects. Ensuring EBD development projects are run to applicable industry standards and best practices.
  • Working with Key Opinion Leaders and Investigators to understand the medical and scientific trends in the field of EBD.
  • Lead internal innovation for EBD ensuring continuous evolution of our products to stay relevant in our markets.
  • Oversee EBD projects ensuring they are run to applicable regulations (such as FDA, ISO 13485, and other relevant regulatory standards) and to time and budget.
  • Serve as the technical voice in executive meetings and external partnerships.
• Cross-functional collaboration:
  • Direct communication with Global Technical Operations to ensure a constant feedback loop in the EBD lifecycle of each product.
  • Lead and engage productive cross-functional teamwork and collaboration with non-R&D functions: Marketing, Patent Affairs, Nonclinical Development, Clinical Development, Project management, R&D QA and GTO QA.
  • Support Corporate Development due diligence projects
  • Support regulatory submissions and audits, as needed
• Outsourcing:
  • Management and oversight of R&D EBD outsourced projects and vendors.
• Change management:
  • Promote a culture of innovation and continuous improvement within EBD team and actively lead these efforts. Promote effective change.
  • Actively create an open and trust-building working environment
• Budget and resource management:
  • Adequate planning and controlling of resources in the EBD team
  • Budget management of the EBD cost center
• Leadership:
  • Articulate a clear and compelling vision aligned with the global cultural tenets and strategic objectives of the company.
  • Clearly define roles and responsibilities while holding members accountable for their performance.
  • Develop talent and skills of individual team members.
  • Empower leaders and employees to make informed decisions, enabling autonomy while providing guidance and support.

Minimum Requirements:

• Bachelor of Science (B.S.) or related field
• 15+ years of early and late-stage EBD experience
• 7+ years experience in people management and leadership
• Supply chain/production floor experience
• Product Launch experience
• Proven track record of bringing Class II or Class III medical devices to market
• Six sigma qualification or similar

 Preferred Qualifications:

• Master's Degree or PhD or other higher-level degree

 Technical & Functional Skills

• Executive presence and exceptional presentation skills
• Experience in working with matrixed global teams across multiple time zones
• Advanced skills in Microsoft Excel, PowerPoint and Word
• Excellent written, oral, and interpersonal communication skills
• Demonstrated history of teamwork and cross functional collaboration
• Strong knowledge of design controls, risk management, and product lifecycle management
• Excellent leadership, communication, and project management skills
• Deep understanding of medical device design and development
• Knowledge of biomedical engineering, mechanical/electrical systems, and embedded software
• Experience with Class II/III medical devices and regulatory standards (FDA, ISO 13485, IEC62304, IEC 60601)

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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