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Job Title: Sr Engineer - Reliability and Processing
* Implements/enhances state-of-the-art quality and reliability systems/programs to support R&D objectives relating to instruments and consumables (excluding software)
* Reviews/critiques product designs, proposed processes, and testing regimens with the objective of ensuring a rigorous focus on reliability, quality, and compliance throughout development process
* Contributes unique expertise in key aspects of product design, including reliability, compliance, sterilization, and preproduction quality engineering design principles
* Provides technical resources and methods to teams implementing design for reliability, and manufacturing (example: HALT chamber, robots, test selection, external labs, etc)
* Provides essential analytical skills in statistical analysis, tolerancing/simulation, measurement science, stress testing, reliability assessment, simulation, and evaluating alternate components.
* Ensures teams identify and execute key pre-verification characterization testing and review activities necessary for product improvement and robustness enhancement
* Coordinates HALT, environmental, transportation, verification life testing, sterilization validations, cleaning validations, drying validations, PCBA stress screening, and other testing/V&V to ensure timely and efficacious completion of R&D development projects
* Supports R&D MS&T group with a focus on approved MS&T-sponsored projects
* Works with project teams to ensure DHF reports, verifications and validations are compliant, documented, and grounded in solid science.
* >6 yrs with BS Degree or four years with a MS Degree. Medical Device industry experience preferred. * Must include at least 4 yrs in R&D with primary focus on preproduction reliability and quality engineering activities.
* Proven experience in the application of reliability engineering, including:
* Some familiarity required in applying basic statistical methods
* Practical knowledge in common failure mechanisms found on Opto-Electro-Mechanical system
* In-depth understanding of reliability testing such as HALT, Accelerated Life Test (ALT), Environmental Tests, Shock & Vibration, and Transportation test
* Must be familiar with GMP/QSR (regulations and standards)
* Some experience required in fixturing, lab testing methods and/or equipment validation
* Preferred familiarity with reprocessing methods and related equipment
* Proven strong learning agility required
* 1-2 years of experience in executing process validation, transfer of products from R&D into manufacturing, and working on multidisciplinary teams that include all functions in the manufacturing environment.
* Proven knowledge in mechanical, electrical, or optical design principles. This person must be able to critique designs for their manufacturability.
* Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
* BSc. in Engineering (Chemical, Industrial, Mechanical or Electrical) or Physical/Biological Science * MS and ASQ Certifications in Quality Engineering and Reliability Engineering preferred. * Fluent in English
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