Work Flexibility: Onsite
Permanent hybrid role based in #carrigtwohill, Cork
Responsibilities
* Prepare specifications for product safety and performance testing with a high degree of complexity (i.e. creation of test plans and complex test protocols). Typical products may be additive manufactured arthroplasty and trauma products as well as instruments required for implantation.
* Project planning of product safety and performance tests and test campaigns.
* Execute product safety and performance tests including documentation in test reports and approval thereof.
* Analyze and assess results gained utilizing adequate analytical and statistical means and methods according to pre-existing guidelines.
* Analyze and calculate loads (forces and moments) acting in the human body as input to simulations and calculations of implant loading as well as for adequate layout mechanical test set-ups.
* Manage external test projects (i. e. sterilizations validations, cleaning validations, biocompatibility testing, electromagnetic testing).
* Communicate, discuss and conclude test and analysis results in cooperation with product development teams
* Consult development Engineers in biomechanical questions.
* Prepare and create new guidelines (standard operating procedures).
* Communicate on best practices and methodologies and share those across sites with subject matter experts from other sites.
* Oversee subject matter expertise related to international standardization (ISO, ASTM, FDA guidance, others) and implement requirements into guidelines.
* Functionally lead the work of technicians, specialists and project engineers in the field of Biomechanics.
Requirements
* Bachelor's Degree in Engineering or related
* Minimum of 2-3 years of relevant experience in the medical device industry or equivalent.
* Demonstrated ability to successfully contribute to complex ver/val test campaigns and lead less complex test campaigns.
* Demonstrated ability to apply lab related design controls within a regulated industry.
* Demonstrated knowledge and ability to apply fundamental and some advanced concepts, practices and procedures of practical field of specialization.
Travel Percentage: 10%