Direct the sustaining engineering activities of SynCardia Products including all of the accessories that form the complete product offering
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
Author test protocols for Freedom and Companion Family testing
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
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
Bachelor’s Degree in an Engineering/Biological Science discipline or equivalent
Seven 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
Proven track record of leading teams and managing technical personnel in product design, development and transfer to manufacturing
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.
Interested in applying for this position? Please send your cover letter and resume to firstname.lastname@example.org