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Sr. Engineer - Disposables R&D, Sustaining

Plymouth, MN 55441

Posted: 09/30/2025 Employment Type: Contract Job Category: Engineering Job Number: 621088 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 30-34.49/hr **salary will be commensurate with experience 

Job Description:

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

Essential Duties and Responsibilities: 
• 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 disposable
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About Plymouth, MN

Ready to take the next step in your career? Explore job opportunities in the vibrant Plymouth, Minnesota area! Known for its picturesque parks, including the popular French Regional Park and the stunning golf course at Rush Creek, Plymouth offers a perfect blend of urban convenience and natural beauty. Home to iconic landmarks like Minnetonka Theatre and Eddington House, this bustling city boasts a rich arts scene and a thriving culinary landscape. Cheer on the local sports heroes at the nearby Target Center or take a leisurely stroll through the charming shops at The Shoppes at Arbor Lakes. With a plethora of opportunities for professional growth and a welcoming community atmosphere, Plymouth is the ideal place to grow your career. Browse our job listings today and discover your next adventure in this amazing city!