Sr Reliability Engineer - Exempt

Job Title

A Day in the Life

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.

Must Have:
Minimum Requirements

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.

Nice to Have

• 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.