Principal R&D Engineer
Principal R&D Engineer
Posted on :
15-05-2025
Employer Active
1 Vacancy
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Job Description
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 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 riskbased 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 crossfunctional 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.
- 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.
- Selfdirected resourceful and able to manage multiple priorities.
- Strong interpersonal communication collaboration and influencing skills.
- Ability to read write and comprehend English.
Employment Type
Full Time
Key Skills
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