Planet Pharma
Reliability Engineer II (Software Safety Engineer II)
Planet Pharma, Mounds View, Minnesota, United States
Job Description
Careers That Change Lives
We push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
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
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. 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.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. This company walks the walk, creating an inclusive culture where you can thrive.
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.
Qualifications -
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Careers That Change Lives
We push the limits of what technology can do to make tomorrow better than yesterday and that makes it an exciting and rewarding place to work. We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
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
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. 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.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result -and everyone wins. This company walks the walk, creating an inclusive culture where you can thrive.
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.
Qualifications -
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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.