Sr. Engineer - Disposables R&D, Sustaining

Job Title: Sr. Engineer - Disposables R&D, Sustaining

Location: Plymouth MN

Duration:12 Months

Supports design and development of product changes, within sustaining engineering, for disposable medical devices.

Essential Duties and 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.

* Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (e.g. new features, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).

* Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).

* Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings.

* Develop and execute test method validations, product testing, and verification / validation activities.

* Build prototypes and models. May operate machine tools, design and build basic tooling, test fixtures and assembly equipment.

* Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

List knowledge, skills, and/or abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

* Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.

* Working knowledge of CAD and PDM enterprise software (e.g. Creo, Solidworks).

* Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.

* Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.

* Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.

* Strong collaboration, verbal and written communication skills.

* Strong attention to detail, organized, and able to independently manage multiple priorities.

* Ability to read, write and comprehend English.

Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.

* 3 - 5 years of related experience in Class II or Class III disposables medical product development.

* Design for Six Sigma (DFSS) training or certification preferred.