Performs functions to design or develop new or existing catheter based company products. Creates requirement specifications to design and develop new components or redesign existing components to improve company products.
Applies the practical application of the principles of engineering for the development and utilization of products, instrumentation, processes, and services. Considerable attention is given to research, design, manufacturing, testing, calibration, procurement, and operations.
ESSENTIAL RESPONSIBILITIES:
Applies novel ideas, engineering concepts, and new technology to improve existing products and develop new products
Determines and establishes project requirements, specifications, and guidelines through engineering calculations and layouts
May perform project engineer leadership duties by management of a product development project and associated duties
Participates in and/or hosts design reviews using design control guidelines as well as verification and validation protocol writing, execution and report generation efforts
Works within engineering design control system per FDA and notified body guidelines
May give direction to engineering technicians and other employees in subordinate positions
May participate in Corrective Action Requests (CAR) and / or product Defect Reports (DR) resolution.
May at times manage development subcontractor(s) for their design services
May occasionally converse with doctors and / or customers pertaining to product issues or questions.
Creates design drawings, material stackup analysis, tolerance computations, etc
Composes test protocols, memos, reports, technical procedure manuals, and general correspondence
Prepares, product specification document(s), cost estimates, reports, proposals, and presentations
Communicates with vendors to obtain information and assistance
Builds prototype/ model products
Supports other groups within the company when applicable
Investigates catheter related manufacturing issues
Other duties as assigned by Department Manager.
EDUCATION, EXPERIENCE & KNOWLEDGE
Bachelor’s Degree (BS in mechanical or biomedical engineering) from four-year college or university.
One to two years related experience and/ or training; or equivalent combination of education and experience working in a medical device environment.
Software knowledge: Word, Excel, Internet Explorer, SolidWorks, Auto Cad, Labview, manufacturing software, configuration management software, Power Point, Microsoft Project
Knowledge of developing a product from concept to full production release, especially relating to catheter products is a plus.
Qualified Candidates
Qualified candidates for this position should submit their resumes to hr@millarmail.com
Millar
Instruments, Inc. | 6001-A Gulf Freeway Houston,
Texas 77023-5417 USA | 832.667.7000