Job Description:This section focuses on the main purpose of the job in one to four sentences. Leads design and development of product changes within sustaining engineering for disposable medical devices.
Responsibilities: - This section contains a list of primary responsibilities of this role that account for 5% or more of the work.
- The incumbent will perform other duties assigned.
- Schedule, budget, and lead engineering projects with minimal guidance.
- Serve as the technical expert for design change programs. (e.g. new products, suppliers, materials, labeling, CAPA/Client, cost reduction, remediation).
- Identify, investigate, and solve complex engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).
- 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: - BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
- 5 - 8 years of related experience in Class II or Class III disposables medical product development.
- Advanced knowledge of plastics materials and processing such as 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 (e.g. Creo, Solid works).
- Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
- Creative Problem Solver - identify technical risks up front, develop and execute mitigations and provide team direction on how to remove or avoid roadblocks.
- Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.
- Ability to train and coach others from technical expertise.
- Self-directed, resourceful, and able to manage multiple priorities.
- Strong interpersonal, communication, collaboration and influencing skills.
- Ability to read, write and comprehend English.
