Principal Engineer, Quality, Baxter

Baxter

Location:

United States, Milwaukee

Category:

-

Contract Type:

Employment contract

Salary:

104000.00 - 143000.00 USD / Year

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Job Description:

As a Principal Engineer, Product Quality, you will ensure the establishment and execution of world-class Design Control processes that deliver safe and reliable products, while also enabling speed to market. You will partner with the Sustaining Engineering team in the design maintenance of FDA Class I and Class II medical devices to ensure that design control principles are followed, and that safety & efficacy are demonstrated. At all times throughout the process, you will identify and mitigate risks.

Job Responsibility:

Provide quality assurance support and oversight 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 requirements' 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, striving for a world-class Product Development Process

Requirements:

Bachelor’s Degree in Engineering
5+ years’ experience in medical device or other regulated technical industry (e.g., aerospace, automotive, defense)
Experience with development of mechanical or electronic devices is required
Experience with manufacturing & software development 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
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

Nice to have:

Experience with manufacturing & software development 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), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits

Additional Information:

Job Posted:

March 20, 2025

Employment Type:

Fulltime

Work Type:

Hybrid work

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Principal Engineer, Quality