About the Role
The Reliability Engineer will be responsible for supporting the development and testing of new products and components, and changes to existing products and components. This position interacts directly with design and operations engineering and design quality, as well as third-party test firms.
Key Activities
Conduct review and test at key stages of product development for product reliability and performance, compliance with regulatory standards, engineering principles, company procedures and policies, customer requirements and related specifications.
Support the development of test methods, test method validation, collection of data, and report writing.
Collaborate closely with design and quality engineering to develop strategies, plans and specific methods for system-level, electromechanical testing. Priority focus on reliability and accuracy.
Write protocols to support testing objectives in collaboration with design and quality engineers.
Collaborate with Quality and Design Engineering to identify and understand relevant standards to ensure the scope of testing complies.
Document the manufacture and inspection of test products in compliance with the company’s quality system.
Prepare, set up, and conduct experiments and tests related to both test methods and product testing.
Conduct root cause investigations and analyses, and write supporting reports.
Build and set up test and assembly equipment.
Make and build models and fixtures using assembly techniques and fabrication skills for electromechanical devices.
Read and follow drawings and documents for work.
Manage change orders, controlled document release and revisions.
Preferred Skills
13485, ISO 14971, and FDA 21 CFR Part 820, with emphasis on mechanical reliability requirements.
Mechanical Testing & Analysis: Basic experience with mechanical stress testing, fatigue analysis, and failure investigation for precision electromechanical systems.
Education and Experience
BA/BS Engineering-oriented degree.
5+ years of experience in medical device manufacturing.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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