Manages all engineering activities, leads and develops the engineering team. Solves complex performance and operational issues to improve manufacturing processes. Oversee design development, production and testing of product and processes.
Essential Duties and Responsibilities:
- Evaluate all sensor applicator device assembly processes related to scaling, development, and process improvement to enhance product quality, decrease cost, and improve manufacturing efficiencies.
- Manage engineering resources and lead the team to scale and enhance new automation equipment, further develop assembly processes, and inspections to meet high volume targets.
- Evaluate various processing/assembly strategies and produce parallel mitigation plans to ensure volume targets can be met.
- Resolve escalated issues arising from operations and coordinate with other supporting departments.
- Manage outcomes with cross functional departments in the areas of Supply Chain, Quality Assurance, Supplier Quality, Regulatory, and Manufacturing.
- Check technical accuracy of work, ensure the team's Design of Experiments (DOE) are appropriate, and review statistical methods used to estimate future manufacturing requirements, production and field performance data.
- Support Engineering teams at various sites in Arizona and Contract Manufacturers.
- Provide vision and make strategic decisions that affect the functional area of responsibility.
- Give input into developing the budget.
- Build, guide, and enhance the process engineering team to meet future needs. Mentor and engage employees to gain work efficiencies and perform performance reviews.
- Proven track record in commercialization, and manufacture of medical devices and/or medical diagnostic products along with some leadership experience.
- Proficiency with engineering software tools for CAD(SolidWorks), statistical analysis JMP or Minitab.
- Ability to manage projects, teams, timelines, and transfer new technologies and processes.
- Typically requires minimum of 8-12 years of related industry experience.
- Typically requires 2-4 years of leadership experience.
- Master's or PhD preferred
FUNCTIONAL DESCRIPTION: Management
Oversees the activities related to the technical support and process development engineering functions of a manufacturing area. Plans and implements the development of new and scale-up process formulas. Establishes operating equipment specifications and acts as a liaison with product design and development to ensure processes and designs are compatible. Leads efforts to achieve cost effectiveness and improved product quality. Selects, develops, and evaluates personnel to ensure the efficient operation of the function.
- Knowledge and awareness spans all aspects of the specific functional area.
- Having wide-ranging experience, uses professional concepts and knowledge of company objectives to resolve complex issues in creative and effective ways.
- Develops a proficiency of the company's business / market in order to inform decisions.
- Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.
- Provides guidance to team members / supporting employees using established company policies.
- Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company.