Essential Duties and Responsibilities
Department Specific Duties and Responsibilities
- Support the sustaining engineering activities of SynCardia Products including all of the accessories that form the complete product offering
Position Specific Duties and Responsibilities
- Participates as a team member on product design teams and performs related design functions; including equipment design and trouble-shooting, analysis, and technical writing.
- Analyzes problems in design, process, and test development. Recommend/implement solutions.
- Prepares and presents oral and written project updates and technical discussions.
- Provides technical support/guidance on components, materials, methods, systems and equipment.
- Develops physical and functional test requirements to ensure specifications are met.
- Writes and approves protocols and reports.
- Manages testing outlined in protocols and test methods.
- Manages/develops validation studies on equipment and processes.
- Plans and coordinates engineering test builds.
- Maintains a professional working relationship with internal and external customers and support staff.
- Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
- Understands and follows company procedures and regulatory requirements.
- Develops and implements procedures/policy. Provide technical support with existing manufacturing processes for driver systems to maintain and improve quality, improve first pass yields and reduce variability in manufacturing process
- Provide support for quality problem solving and continuous improvement in manufacturing
- Actively participate in design transfer of new products into manufacturing ensuring quality documentation requirements are achieved
Role Specific Duties and Responsibilities
- Support design process to ensure that all design activity occurs within FDA and ISO guidelines
- In conjunction with Operations and Quality, establish manufacturing processes, including tolerance limits, to achieve design intent
- Design and implement necessary tooling and fixtures to improve operating efficiencies and consistent quality
- Responsibility and Authority Affecting Quality
- Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System.
- Identify and record potential problems relating to the product, process and Quality System.
- Initiate, recommend or provide solutions through designated channels.
- Record and/or report all instances of customer feedback on product.
- Verify the implementation of solutions
Skills and abilities (required for the job)
- Excellent communication skills,
- Excellent writing skills,
- Strong organizational skills,
- Detail oriented / Attention to detail,
- Ability to handle multiple tasks simultaneously,
- A team player / collaborative
- Ability to work independently
Education, experience and training (required for the job)
- Bachelor’s Degree in an Engineering/Biological Science discipline or equivalent
- Five to ten years’ experience as a Process / Design Engineer with a thorough understanding of new product design and design transfer, process control and establishing a design development plan in a regulated industry
- Thorough understanding of design philosophies, principles, systems, methods, tools, standards, organizational and team dynamics customer expectations and satisfaction, supplier relations and performance, leadership, training, interpersonal relationships, improvement systems, and professional ethics
- Ability to plan, control and assure product and process quality in accordance with quality principles which include planning processes, material control, acceptance sampling, and measurement systems
- Thorough knowledge of statistical analysis, reliability, maintainability and risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting
- Ability to acquire and analyze manufacturing data using appropriate standard quantitative and statistical methods across a spectrum of business environments to facilitate process analysis and improvement
1. Work Station Area: Office
2. Special Factors in the Work Area: None
The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
The position requires the ability to communicate in person, telephonically and via email.