Provides guidance for the design and development of company products. Works closely with product development team to establish product development goals while ensuring market compatibility.
• Formulates and implements research and development programs, policies, and procedures required to support profitable growth.
• Provides design/development teams with appropriate resources to perform assigned tasks.
• Interfaces with appropriate internal and external resources to ensure intellectual property is appropriately protected.
• Interfaces with appropriate internal and external resources (regulatory, customers, etc.) to ensure development programs meet regulatory and customer requirements.
• Provides technical assistance for diagnosing design and manufacturing quality problems.
• Guides development and documentation of test plan protocols, standard operating procedures, specifications and test procedures.
• Contributes to business unit and divisional strategy planning.
• Participates in review boards for intellectual property, CAPA, complaints, business unit planning, and others as necessary.
• Reviews and provides functional approval for project and quality system documentation.
• Develops and manages organizational plans and resources for the specific department and business units for which they are responsible.
• Provides mentorship and career development oversight for direct report employees.
• Tracks and forecasts divisional and product and technology projects
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.
• Four-year degree (Engineering) in a technical field, preferably mechanical, chemical, biomedical, industrial, or quality engineering; materials science, biochemistry, chemistry, physics or management is REQUIRED.
• Master’s or PhD degree in a technical or business field is preferred.
• Minimum of six plus years’ experience in medical device design experience is REQUIRED
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to travel approximately 25%, including internationally.
• Ability to maintain regular and predictable attendance.