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.
This role will be posted for a minimum of 3 days.
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