Baxter International Inc.
Principal Risk Engineer
Baxter International Inc., Round Lake, Illinois, United States, 60073
Overview
Be among the first 25 applicants. This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter
As a Principal Risk Engineer, you will collaborate with cross-functional teams to design complex medical devices that meet customer needs and regulatory standards. This role applies ISO 14971 standard risk management principles, methods, and techniques to ensure products meet medical device design control standards. A Principal Risk Engineer plans and delivers engineering assignments under the guidance of the Product Risk Management Owner.
What you will be doing
Engaged member of the team as a systems risk management engineer of moderate to high complexity devices.
Coordinates efforts of cross functional teams and/or integrates cross functional inputs to delivery of a project of moderate technical and strategic complexity.
Analyzes complex designs across engineering disciplines, documenting risks and ensuring risk controls and requirements are met.
Manages the Design History File (DHF) and ensures the risk management file is up to date and within compliance.
Ensures cross-functional review, discussion and debate of input; identifies and prepares appropriate stakeholders within functional, program and/or project team to make decisions.
Ensures inclusion of inputs into product and technical design reviews from all cross functional stakeholders.
Anticipates technical challenges and risk scenarios and prepares, manages, and implements mitigation strategies to ensure optimal results.
Understands and contributes to resolution of competing constraints among inter-related functions (e.g. engineering, manufacturing, regulatory, marketing, medical) required to deliver products to market.
Uses creative thinking and teamwork to resolve conflicts.
Makes proficient and disciplined decisions and systems deliverables (e.g. program milestones, technical design reviews).
Embraces team and management decisions while also raising issues to appropriate level.
Works with Project Management to create and manage schedules for systems and sub-systems.
Designs to meet regulatory requirements as determined by FDA, ISO, and IEC standards.
What you will bring
B.S. or M.S in Engineering (Mechanical, Electrical, or Software) with 5+ years of Software, Electrical, or Mechanical Engineering experience.
Preferred: Minimum of 5 years of relevant experience in medical device industry.
Preferred: Previous design experience i.e., design inputs and outputs and the design review process.
Cross-functional team collaboration experience, including technical and non-technical work.
Success in delivering results on technical challenges including investigative and problem-solving skills.
Has organized and presented technical and project overviews without assistance.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.
Compensation and Benefits We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 - $143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Benefits and Equal Employment Opportunity Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, insurance for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), and the 401(k) Retirement Savings Plan (RSP) with employer matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits (paid holidays, paid time off 20–35 days, family and medical leaves of absence, paid parental leave). Other benefits include commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), and childcare benefits. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please contact us.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams. To learn how you can protect yourself, review our Recruitment Fraud Notice.
#J-18808-Ljbffr
Be among the first 25 applicants. This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. Here, you will find more than just a job—you will find purpose and pride. Your role at Baxter
As a Principal Risk Engineer, you will collaborate with cross-functional teams to design complex medical devices that meet customer needs and regulatory standards. This role applies ISO 14971 standard risk management principles, methods, and techniques to ensure products meet medical device design control standards. A Principal Risk Engineer plans and delivers engineering assignments under the guidance of the Product Risk Management Owner.
What you will be doing
Engaged member of the team as a systems risk management engineer of moderate to high complexity devices.
Coordinates efforts of cross functional teams and/or integrates cross functional inputs to delivery of a project of moderate technical and strategic complexity.
Analyzes complex designs across engineering disciplines, documenting risks and ensuring risk controls and requirements are met.
Manages the Design History File (DHF) and ensures the risk management file is up to date and within compliance.
Ensures cross-functional review, discussion and debate of input; identifies and prepares appropriate stakeholders within functional, program and/or project team to make decisions.
Ensures inclusion of inputs into product and technical design reviews from all cross functional stakeholders.
Anticipates technical challenges and risk scenarios and prepares, manages, and implements mitigation strategies to ensure optimal results.
Understands and contributes to resolution of competing constraints among inter-related functions (e.g. engineering, manufacturing, regulatory, marketing, medical) required to deliver products to market.
Uses creative thinking and teamwork to resolve conflicts.
Makes proficient and disciplined decisions and systems deliverables (e.g. program milestones, technical design reviews).
Embraces team and management decisions while also raising issues to appropriate level.
Works with Project Management to create and manage schedules for systems and sub-systems.
Designs to meet regulatory requirements as determined by FDA, ISO, and IEC standards.
What you will bring
B.S. or M.S in Engineering (Mechanical, Electrical, or Software) with 5+ years of Software, Electrical, or Mechanical Engineering experience.
Preferred: Minimum of 5 years of relevant experience in medical device industry.
Preferred: Previous design experience i.e., design inputs and outputs and the design review process.
Cross-functional team collaboration experience, including technical and non-technical work.
Success in delivering results on technical challenges including investigative and problem-solving skills.
Has organized and presented technical and project overviews without assistance.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change.
Compensation and Benefits We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 - $143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.
Benefits and Equal Employment Opportunity Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, insurance for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), and the 401(k) Retirement Savings Plan (RSP) with employer matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits (paid holidays, paid time off 20–35 days, family and medical leaves of absence, paid parental leave). Other benefits include commuting benefits, Employee Discount Program, Employee Assistance Program (EAP), and childcare benefits. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please contact us.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams. To learn how you can protect yourself, review our Recruitment Fraud Notice.
#J-18808-Ljbffr