Job Summary:
The Senior Materials Engineer will be responsible for selecting, testing, and implementing next generation materials used on established catheter platforms as well as supporting new process and product development. Will work with suppliers on obsolescence risk management of component supplies and technical support for any component quality issues. This is an individual contributor position, as such, the candidate will need to be hands on, a self-starter, and work with moderate supervision.
Responsibilities:
Identify, procure, and qualify alternate materials as replacements for discontinued resins
Develop and maintain a risk mitigation plan for components at risk
Coordinates verification and validation activities such as writing plans and reports fabricating devices and supervising technicians
Support new product development including material and supplier selection, process development and resolution of manufacturability challenges
Documents components, designs, processes and tools
Liaison to the Operations Group; transfers new components / products and process to operations
Maintains laboratory equipment, notebook and current training record
Performs other duties as required
Qualifications: Education:
Bachelor's degree in Materials Science, Plastics Engineering or Mechanical Engineering
Knowledge and Experience (Scope & Complexity):
5+ years of focused catheter development experience (preferred) or 7 years equivalent product development experience in other FDA regulated environments
Demonstrated strong Solidworks experience or other design software tools
Experience designing plastic components and assembly processes using a range of polymeric based materials; such as Nylon 12, Pebax and co-polyester Elastomers, Polyolefins, and engineering plastics like polyimide, PEEK and PTFE
Demonstrated knowledge of major polymer processing techniques, including extrusion, blow molding, balloon blowing, injection molding, and thermoforming operations
Practical experience with adhesive chemistry and processing methods
Practical understanding of variation statistics (ANOVA), Design of Experiments (DOE), SPC, process validation and design control
Practical exposure to Project Management Tools. The successful candidate will demonstrate successful completion of a cradle to grave project, including document control requirements for project phases
Knowledge of Microsoft Office Products and other computer applications (i.e.: Word, Excel, PowerPoint & Project, Windows, Visio, etc.)
Knowledge of proper English usage, grammar, spelling, vocabulary and of generally accepted office practices, procedures and equipment
Skills and Abilities:
Ability to work with external material and engineering vendors
Ability to communicate effectively, both oral and written, in order to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates
Ability to exercise independent judgment consistent with department guidelines
Ability to organize and prioritize workflow and to meet established timeframes
Ability to maintain up-to-date knowledge of procedures, products and activities of assigned area
Problem Solving & Decision Making:
Ability to assess a problem quickly and determine to what level it should be elevated, directing staff/customers to the correct person(s)
Effective use of problem solving tools
Physical Requirements:
Ability to hear and speak to employees and outside business associates on the phone and in person
Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)
Ability to consistently work using a high powered microscope
Requires good manual dexterity for the assembly of small plastic components and use of personal computer
Supervisory Responsibility:
May oversee engineering technicians
Travel Requirements:
Some travel to external vendors required
It is the policy of Volcano Corporation, to base all employment decisions on the principles of equal employment opportunity and to take affirmative action in the employment of women, minorities, individuals with disabilities, and veterans.
Volcano Corporation - 9 months ago
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