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%