Senior Director of Operations

POSITION SUMMARY

The Senior Director, Global Operations (Sr Dir, Ops) is responsible for leading the Company’s operations function for all the Company’s products, excluding Solutions. Included in this role are supply chain, warehousing, logistics, repair, fulfillment and associated operations functions in support of both existing as well as future products. This role reports to the SVP, Operations and R&D, and is responsible for ensuring that all departmental organizational operations and essential functions of the position (as defined herein below), align with the overall strategic, operating, and financial initiatives of the Company.

This position is responsible for establishing strategy and managing both internal teams and external resources, including all 3rd party services providers required for delivery of the operations functions, at the highest level of operational excellence and quality.

All Operations leadership and/or team members as defined by the organizational structure

• Effectively develop and implement an operations strategy to support the current and future needs of the Company.
• Manage staff direct reports; identify personnel needs, perform hiring, talent development and mentoring of all department staff in coordination with the Company’s HR department.
• Establish and oversee contracts, relationships and performance management of operations all 3rd party services, including the creation, ownership and leverage of an operations supplier performance system
• Establish and own an effective vision and culture of excellence for operations function, aligned with the culture of the Company.
• Develop and maintain effective processes to ensure consistent and high-quality deliverables and support the Company’s quality management system (QMS).
• Drive operational excellence throughout the organization through the development of standard work, best practices, and direct leadership coaching.
• Ensure that departmental staff, reporting structures, and activities support the Company’s overall business strategy and Quality System performance.
• Provide competent and ethical leadership in pursuit of departmental and Company wide goals and objectives.
• Build and maintain strong partnership relationships with peer Operations, Solutions and R&D senior leaders, as well as partners across the Company.
• Continuously strive for excellence in all undertakings and creating a culture of same for area of responsibility.
• Perform strategic planning, budgeting, and forecasting for all areas of responsibility in consultation with relevant colleagues and your senior leadership.
• Regularly coordinate with executive leadership of the Company to develop and achieve Company-wide goals while providing expertise and recommendations for new or improved processes, technologies and systems.
• Maintain working knowledge of new materials, technologies, and processes relevant to the Company’s present and anticipated products and operations needs.
• Other duties as assigned.

Education/Training/ Certifications/Licenses:

• Bachelor’s degree in Engineering, Operations, Manufacturing or comparable education with experience.

Experience:

• 10 years operations leadership experience with 5 years at senior management level in FDA regulated industries with demonstrated experience and work history in regulated medical devices.
• Demonstrated experience in Supply Chain development and management, including contract negotiation and supplier performance management.
• Demonstrated ability to successfully interact with regulatory agencies such as FDA.
• Familiarity with FDA cGMP, ISO 13485 and IEC 60601 requirements.
• General understanding of US Generally Accepted Accounting Principles (GAAP) compliance.

Skills/Abilities
:

• Effective team and organizational leadership including cross-functional collaboration and influence.
• Effective at managing change; leading and communicating to address change within the structured methodology of your field.
• Extensive knowledge of manufacturing, materials planning and supply chain management processes and systems
• Capability to identify and resolve complex problems in a timely manner.
• Extensive knowledge of ERP, Warehouse Management and Manufacturing tools
• Working knowledge of document management suites (PLM) such as Arena.
• Working knowledge of Microsoft business software products.
• Excellent interpersonal and organizational skills.
• Excellent oral and written communication skills.

• Sit/Stand: 90%/10%
• Manual Dexterity:
  Ability to assemble/disassemble and troubleshoot products
• Work Environment:
  Normal office environment.
• Travel: 30% including overnight travel, Domestic and International