Sr Reliability Engineer
1 week ago
Responsibilities may include the following and other duties may be assigned:
- Leverages relevant field experience and/or clinical knowledge to ensure the practical applicability and safety of our products in real-world settings.
- Completes risk severity and occurrence determination and analyzes risk benefit profiles for cardiac software medical products.
- Completes risk analysis studies of new design and processes.
- Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
- Ensures that corrective measures meet acceptable reliability standards.
- Analyzes preliminary plans and develops reliability/safety engineering programs to achieve company, customer, and governmental agency reliability/safety objectives.
- Develops, coordinates, and conducts technical reliability/safety studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
- Recommends design or test methods and statistical process control procedures for achieving required levels of product reliability and safety.
- Proposes changes in design or formulation to improve system and/or process reliability and product safety.
To be considered for this role, please ensure the minimum requirements are evident on your resume:
- Bachelor's degree in engineering, science, or technical field with 4 years of work experience in engineering and/or quality OR advanced degree in engineering, science, or technical field with 2 years of work experience in engineering and/or quality.
- Qualified to assess patient safety risks via one of the following:
- Medical doctor with related device experience
- Engineer who has achieved IBHRE or NASPE Exam certification
- Personnel with at least 5 years of clinical field experience in the past 15 years such as Nurse, Clinical Specialist, Technical Field Educator, Field Clinical Engineer, or Technical Services (cardiac products)
- Personnel with at least 5 years of previous clinical experience related to cardiac therapy products.
- Advanced degree in engineering or science.
- Proven understanding of product reliability/safety engineering principles.
- Strong understanding of and experience in the application of statistics, including experience with Minitab.
- Experience in a highly regulated industry, preferably implantable medical devices.
- Experience with 21 CFR Part 820 (Quality System Regulation), ISO 13485, etc.
- Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, HA, FTA, DFMEA).
- Ability to independently lead investigations to identify system/product failures, hazards, hazardous situations, and harms.
- Certified Software Reliability Engineer (CSRE) certified.
- Exposure to or experience working in or with design, quality, regulatory, clinical, and/or manufacturing.
- Experience in the design, maintenance, or continuation engineering of released software or software systems, including mobile applications.
- Knowledge of Design for Reliability (DfR), Design for Reliability and Manufacturability (DRM), Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), and/or robust design practices.
Join us at our Mounds View, MN location, where innovation meets opportunity, and contribute to developing reliable and safe cardiac software medical products.
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