Principal Engineer

2 days ago

Minneapolis, Minnesota, United States Baxter Full time
Job Summary

Baxter is seeking a highly skilled Principal Engineer to lead the design and development of disposable medical devices. As a key member of our team, you will be responsible for scheduling, budgeting, and leading engineering projects with minimal guidance.

Key Responsibilities
  • Serve as the technical expert for design change programs, including new products, suppliers, materials, labeling, CAPA/NCR, cost reduction, and remediation.
  • Identify, investigate, and solve complex engineering problems using risk-based and customer-focused approaches and engineering tools.
  • Lead the creation and maintenance of design history files.
  • Coordinate and communicate the efforts of R&D in collaboration with global cross-functional stakeholders.
  • Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
  • May supervise engineers and/or technicians.
  • May contribute to Baxter intellectual property through invention disclosures and patent applications.
Requirements
  • Advanced knowledge of plastics materials and processing, including injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
  • Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
  • Working knowledge of CAD design and PDM enterprise software, such as Creo and Solidworks.
  • Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
  • Creative problem-solving skills, including identifying technical risks and developing mitigations.
  • Ability to train and coach others from technical expertise.
  • Self-directed, resourceful, and able to manage multiple priorities.
Qualifications
  • BS in Mechanical, Plastics, Biomedical Engineering, or a related field; MS preferred.
  • 5-8 years of related experience in Class II or Class III disposable medical product development.
About Baxter

Baxter is committed to supporting the needs for flexibility in the workplace. We offer a flexible workplace policy, which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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 to $143,000 annually.

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.

Baxter is an equal opportunity employer. We evaluate 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.

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