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Product Development Engineer
2 months ago
We are seeking a highly skilled Product Development Engineer to join our team at Baxter Healthcare Corporation. As a Product Development Engineer, you will play a critical role in the design and development of disposable medical devices.
Key Responsibilities- Support R&D projects in the implementation of design changes and product development, including new features, suppliers, materials, labeling, CAPA/NCR, cost reduction, and remediation.
- Identify, investigate, and tackle engineering problems using risk-based and customer-focused approaches and engineering tools, such as dFMEA, Human Factors Engineering, and statistical software.
- Build, modify, and maintain design history file documentation, including protocols, reports, design specifications, labeling, and design drawings.
- Support and complete test method validations, product testing, and verification/validation activities.
- Build prototypes and models, and may operate machine tools, design and build basic tooling, test fixtures, and assembly equipment.
- Carry out design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.
- Understanding of plastics materials and processing, including injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
- Knowledgeable of CAD design and PDM enterprise software, such as Creo and Solidworks.
- Understanding of FDA Design Controls and ISO 13485 Quality Management Systems.
- Experience and/or background in BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
- 2+ years of related experience in Class II or Class III disposables medical product development.
- Design for Six Sigma (DFSS) training or certification preferred.
Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our 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 $80,000 to $110,000 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.
