LanceSoft
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.
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.