Reliability Engineer II - Exempt

We are seeking a dedicated and skilled professional to join our team as a Reliability Engineer. This role requires a detail-oriented, collaborative individual with strong critical thinking skills. The successful candidate will support cardiac surgery capital equipment and single-use catheters.

Key Responsibilities

• Execute Test Method Validation (TMV) and support design verification processes.
• Review project documents as the Quality Representative, ensuring compliance with industry regulations such as 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
• Analyze data using statistical tools like Minitab, focusing on confidence intervals and hypothesis testing.
• Develop and maintain standards for software systems quality operating methods, processes, and procedures.
• Support the development of risk management architecture and Design for Reliability and Manufacturability (DRM) targets.
• Plan and lead test method validation of design verification methods, ensuring product and software performance meets design requirements.
• Complete risk management files for new designs and updates to released products.

Qualifications

• University Degree with a minimum of 2 years of relevant experience, or an advanced degree with no experience required.
• Practical knowledge and demonstrated competence in the job area.
• Ability to work independently with general supervision on larger, moderately complex projects.
• Strong communication skills for internal interactions to share information, gain input, and support decision-making.

Work Environment

This position is a hybrid role, requiring a minimum of 3 days per week onsite, increasing to 4 days per week starting in September. Candidates must be aware of and agree to this requirement.