Principal R&D Engineer

Katalyst HealthCares and Life Sciences • Full-time • Minneapolis, MN, US • $100k - $130k / year • 3w ago

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.