Senior Director, Product Development, EBD

3 weeks ago

Raleigh, North Carolina, United States Merz North America Full time

Sr. Director for EBD product development shapes and executes Merz EBD product strategy along with internal and external stakeholders. A Senior R&D engineering leader who is creative, collaborative and agile, she/he has both strong technical knowledge, and strong management skills. Drawing from her/his extensive experience, lead and mentor a high performing product development team. Able to drive modern engineering principles and practices by implementing relevant techniques, processes, and best practices. Able to balance and maximize both internal and external resources at hand, Works in conjunction with other R&D Departments to ensure project plans are achieved within budget, timeline, and in accordance with Regulatory and Quality Standards, and Company SOPs

Responsibilities
  • New Product Development Execution:
    • Ensures new product concepts and technologies are developed, in accordance with Corporate strategy and product roadmaps and with cross functional input. Ensures delivery of adequate prototype builds to R&D and other cross functional stake holders for scale up.
    • Ensure seamless product development and software engineers within scope, with an appropriate cost/quality ratio, and on time, according to the project plans.
    • Develops appropriate product specifications to drive efficient transfer to manufacturing, safety, and to enhance the customer experience.
    • Ensures timely and robustly written patent applications.
    • Manages design partner and vendor relationships to ensure timely production of product and adherence to contract terms and deliverables.
  • Efficient and effective operational execution:
    • Plans, prepares and maintains an efficient, effective and compliant department operations, processes, and organizational design to effectively deliver on Company strategies and projects.
  • Efficient and effective internal reporting:
    • Ensures effective planning, budgeting, documentation and reporting in accordance with Company SOPs, quality standards and regulatory requirements.
  • Pipeline expansion:
    • Provides design engineering input into internal device roadmaps and in-licensing opportunities.
  • Continuous process improvement:
    • Strategic Vision for Engineering Practices: Ability to set and implement engineering best practices, promote a culture of quality and continuous improvement, and align the engineering team's efforts with the overall business goals.
  • Company performance targets:
    • Ensures MbOs and business unit targets are adhered to in support of product launches.
  • Leadership:
    • Fosters a culture of innovation.
    • Forms partnerships with key functions and senior leaders from across the organization.
    • Ensures effective cross functional collaboration within department and with external stake holders.
    • Leads, develops and manages direct reports and ensures key talents in department are upskilled.
    • Communicates and serves as a role model for Company culture and performance standards.
Technical & Functional Skills:
  • Executive presence and exceptional presentation skills
  • Advanced skills in Microsoft Excel, PowerPoint and Word and comfort with large variety of online meeting tools and AV equipment
  • Excellent written, oral and interpersonal communication skills
  • Demonstrated history of teamwork and cross functional collaboration
  • Excellent grasp of engineering, design and manufacturing principles involving electromechanical devices
  • Strong strategic, problem solving and analytical skills, with attention to detail
  • Decisive leadership style with strong planning, organizational and communications skills
  • Familiarity with IEC 60601, ISO 13485, ISO 14972, and other relevant industrial standards
  • Familiarity with multi country regulatory authority requirements for device testing
  • Self-motivated, flexible, proactive and committed
  • Strong PC skills, including MS Project, Excel and Power Point
  • Ability to write effectively and give effective presentations
Minimum Qualifications:
  • Bachelor's Degree – a 4-year undergraduate degree in Engineering
  • At least 15+ years' experience, thereof 10+ in complex electromechanical medical device development
  • At least 5+ years leadership experience in managing a R&D engineering team and/or function from product ideation to launch
  • Must have one of the following work experience: EBD in the aesthetic field or HIFU Therapy device
Preferred Qualifications:
  • Master's degree or PhD in Engineering or a related discipline is highly desirable
  • Deep and broad knowledge over all fields of responsibility – design and software engineering, transducer development, human factors and project management

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