ATR International
We are seeking a Software Safety Engineer II for a very important client
We put people first in all we do We remain on the leading edge of innovation to ensure that we treat more people We excel in how we operate to deliver the best experiences for people who touch our therapies.
In this exciting role as a Software Safety Engineer II, you will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.
A Day in the Life In general, the following responsibilities apply for the Software Safety Engineer II role This includes, but is not limited to the following:
• Leverage relevant medical technology experience to ensure the practical applicability and safety of our products in real-world settings. • Completes risk severity and occurrence determination and analyze risk benefit profiles for cardiac medical products. • Completes risk analysis studies of new design and processes. • Ensures that corrective measures meet acceptable reliability/safety standards. • Analyzes preliminary plans and supports development of reliability/safety engineering programs to achieve company, customer and governmental agency reliability/safety objectives. • Support 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.
This position offers an exciting opportunity to drive software reliability and safety engineering within dynamic new product development teams for R&D The candidate will be a pivotal member of cross-functional teams, serving as the go-to expert for reliability, safety, and quality functions.
As a core member of the R&D project teams, the Software Safety Engineer II will drive excellence in quality and reliability programs This dynamic role involves supporting Design for Reliability (DfR) initiatives, actively participating in design and risk reviews, and shaping the development of cutting-edge technologies Collaborating with multidisciplinary teams, the position is pivotal in ensuring that innovative solutions meet the highest safety and reliability standards, fostering impactful advancements in patient care.
This position is in Mounds View, MN within the Cardiac Rhythm Management (CRM) Operating Unit and requires on-site presence three days a week
Cardiac Rhythm Management (CRM) Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure
We are comprised of three businesses: • Cardiac Pacing Therapies • Cardiovascular Diagnostics & Services • And Defibrillation Solutions
Requirement:
Must Have - Minimum Requirements TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME Bachelor's degree with 2 years of work experience in engineering and/or quality
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. • 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). • 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. • Previous clinical field experience, specifically with cardiac rhythm management products.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Benefits:
Benefits Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws.
Compensation Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.
Work Authorization ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization.
ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees.
We put people first in all we do We remain on the leading edge of innovation to ensure that we treat more people We excel in how we operate to deliver the best experiences for people who touch our therapies.
In this exciting role as a Software Safety Engineer II, you will have responsibility for ensuring our products exceed the safety and reliability requirements and expectations of patients, clinicians, regulators, and the business.
A Day in the Life In general, the following responsibilities apply for the Software Safety Engineer II role This includes, but is not limited to the following:
• Leverage relevant medical technology experience to ensure the practical applicability and safety of our products in real-world settings. • Completes risk severity and occurrence determination and analyze risk benefit profiles for cardiac medical products. • Completes risk analysis studies of new design and processes. • Ensures that corrective measures meet acceptable reliability/safety standards. • Analyzes preliminary plans and supports development of reliability/safety engineering programs to achieve company, customer and governmental agency reliability/safety objectives. • Support 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.
This position offers an exciting opportunity to drive software reliability and safety engineering within dynamic new product development teams for R&D The candidate will be a pivotal member of cross-functional teams, serving as the go-to expert for reliability, safety, and quality functions.
As a core member of the R&D project teams, the Software Safety Engineer II will drive excellence in quality and reliability programs This dynamic role involves supporting Design for Reliability (DfR) initiatives, actively participating in design and risk reviews, and shaping the development of cutting-edge technologies Collaborating with multidisciplinary teams, the position is pivotal in ensuring that innovative solutions meet the highest safety and reliability standards, fostering impactful advancements in patient care.
This position is in Mounds View, MN within the Cardiac Rhythm Management (CRM) Operating Unit and requires on-site presence three days a week
Cardiac Rhythm Management (CRM) Integrated Operating Unit offers devices and therapies that treat patients with abnormal heart rhythms and heart failure
We are comprised of three businesses: • Cardiac Pacing Therapies • Cardiovascular Diagnostics & Services • And Defibrillation Solutions
Requirement:
Must Have - Minimum Requirements TO BE CONSIDERED FOR THIS ROLE, PLEASE BE SURE THE MINIMUM REQUIREMENTS ARE EVIDENT ON YOUR RESUME Bachelor's degree with 2 years of work experience in engineering and/or quality
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. • 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). • 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. • Previous clinical field experience, specifically with cardiac rhythm management products.
Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.
Benefits:
Benefits Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws.
Compensation Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.
Work Authorization ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization.
ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees.