Principal Engineer, Quality Job at Baxter (Milwaukee)

Job Description

Being an Engineer at Baxter means you play a critical role in helping us achieve our mission to save and sustain lives. From innovative product design through to production and patient delivery, our Engineers are key to delivering results for our customers and patients worldwide. As a Principal Engineer, Quality, you will have the opportunity to lead by example and enjoy mentoring and learning from others. Here, you are trusted to manage your own time and are given opportunities to grow your career as you wish.

Job Responsibility

Provide quality assurance support and guidance for product design activities including Design and Development Planning, Design Input, Design Output, Design Review, Design Verification and Validation, Design Transfer, Design Changes
Ensure compilation and maintenance of product Design History Files
Partner with Sustaining Engineering and Research & Development to ensure design reviews are thorough and robust
Review and approve Design Verification and Validation test plans, protocols and reports
guide the use of robust statistical techniques
Document traceability of requirements through design output and to design verification and/or design validation
Insist on early requirement maturation, early test plan/script development, and design input requirements that are indicative of real world use case environment and customer needs
Review intended use validation for non-product software and tools used in the development process
Actively participate with design teams on developing product Risk Management Files
ensure risk assessments adequately address safety and efficacy and are compliant to the highest standards
Perform DHF audits of other products as an independent reviewer
Support external regulatory and customer audits
Support nonconformance and CAPA investigations and improvement action plans
Collaborate with global Design Assurance team to drive continuous improvement, including development of standard work, aspiring for a world-class Product Development Process

Requirements

Bachelor’s degree in engineering or related field
5+ years’ experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense)
Experience with development of embedded software, and stand-alone software as a medical device is required
Experience with development of mechanical or electronic devices is a plus
Experience with manufacturing processes is a plus
Strong working knowledge of design controls as required by FDA 21 CFR 820.30, European Medical Device Regulation and ISO 13485 product realization
Knowledge of Quality Management Systems beyond design control compliant with FDA 21 CFR 820 and ISO 13485, product safety standards (e.g., IEC and ANSI/AAMI), Human Factors/Usability Engineering, statistical analysis methods, ISO 14971 Risk Management and cybersecurity controls are a plus
ASQ or related quality certification is preferred
Detail oriented with strong organizational and record keeping skills
Problem solving and root cause analysis skills
Systems Engineering knowledge, experience with complex multifunctional systems
Ability to facilitate cross-functional team meetings
Strong written and oral communications skills using English language
ability to succinctly and clearly describe complex issues in meaningful ways
Ability to engage different functions in meaningful discussions and maintain enthusiasm for efforts
Proactive and timely in execution of assigned tasks
Ability to be flexible and adaptable to changing priorities

Nice to have

Experience with development of mechanical or electronic devices
Experience with manufacturing processes
Knowledge of Quality Management Systems beyond design control compliant with FDA 21 CFR 820 and ISO 13485, product safety standards (e.g., IEC and ANSI/AAMI), Human Factors/Usability Engineering, statistical analysis methods, ISO 14971 Risk Management and cybersecurity controls
ASQ or related quality certification

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
educational assistance programs
paid holidays
paid time off ranging from 20 to 35 days based on length of service
family and medical leaves of absence
paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits

Baxter - All Job Offers

Select Country

Principal Engineer, Quality

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?

Principal Engineer, Quality

Principal Supplier Quality Engineer

Principal Metrology Engineer

Principal Fire Engineer

Principal Fire Engineer

Principal Fire Engineer

Principal Engineer - Site Design

Senior / Principal Electrical Engineer

Principal Engineer

Our AI answers in your language