Job Summary:
Develop and execute tests of Class III implantable devices. Ensure that all product requirements are met.
Essential Duties and Responsibilities:
• Design and execute test protocols for engineering, verification, and validation, within an FDA regulated environment.
• Review tests as related to scheduling, risk reduction, mechanical design, and other aspects of product release through human clinical trials.
• Design, build, qualify, and document test fixtures, including IQ/OQ/PQ.
• Consult with contract manufacturers to evaluate and trouble-shoot their test procedures and results. Up to 30% travel to the East Coast and elsewhere may be required.
• Evaluate, organize, and execute V&V tests such as biocompatibility, sterilization, storage, and so on with outside vendors.
• Write clear and complete reports.
• Frequent oral and written communication is required with senior staff and vendors.
Qualification Requirements:
Experience:
• Minimum 5 years hands-on start up experience in a medical device company, including knowledge of Medical Device Design Control and Quality systems.
• Minimum 5 years of test development and execution for implantable systems.
• Minimum 5 years of project management experience.
• Senior level experience with Design of Experiments and statistical processes and standards used in testing.
Education:
Bachelor’s degree in Mechanical Engineering. Master’s degree highly desirable
Knowledge/Skills/Abilities:
• Superb ability to plan ahead in terms of predicting and avoiding technical and schedule risks.
• Excellent demonstrable communications skills, both written and verbal.
• Familiar with requirements and standards for sterilization and biocompatibility testing.
• Knowledge of materials and processes for implantable devices.
• Excellent ability to troubleshoot material and process failures.
• Competence with mechanical design, Solidworks, and test equipment manufacturing methods.
• Familiarity with test equipment interface to PC’s and other electronic equipment.
• Ability to harmoniously work with and coordinate groups of engineers and technicians with diverse experience levels.
