Engineer I – R&D Disposables
Job in
Plymouth, Hennepin County, Minnesota, USA
Listed on 2026-07-31
Listing for:
Jobtailor
Full Time
position Listed on 2026-07-31
Job specializations:
-
Engineering
Manufacturing Engineer, Quality Engineering, Mechanical Engineer, Biomedical Engineer
Job Description & How to Apply Below
- Support R&D projects in the implementation of design changes and product development
- Identify, investigate, and solve engineering problems utilizing risk-based and customer-focused approaches
- Create, modify, and maintain design history file documentation
- Support and execute test method validations and product testing
- Build prototypes and models
- Operate machine tools, design and build basic tooling, test fixtures, and assembly equipment
- BS in Mechanical, Plastics, Biomedical Engineering or a related field
- 0 – 2+ years of related experience in Class II or Class III disposables medical product development
- Design for Six Sigma (DFSS) training or certification preferred
- Understanding of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization
- Working knowledge of CAD design and PDM enterprise software (e.g. Creo, Solidworks)
- Understanding of FDA Design Controls and ISO 13485 Quality Management Systems
- Knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices
- Strong collaboration, verbal and written communication skills
- Ability to read, write, and comprehend English
Demonstrates expertise in mechanical and biomedical engineering principles, with a strong focus on product development and design changes for medical devices. Proficient in CAD design, risk management, and quality management systems, ensuring compliance with industry standards.
Highest-signal resume keywords- BS In Mechanical Engineering
- Class II Or Class III Medical Product Development
- Design For Six Sigma (DFSS)
- CAD Design (Creo, Solidworks)
- FDA Design Controls And ISO 13485
- Product Development
- Design History File Documentation
- Test Method Validation
- Prototyping
- Machine Tool Operation
- Injection Molding
- Extrusion
- Ultrasonic Welding
- UV/Solvent Bonding
- Sterilization
- Collaboration
- Verbal Communication
- Written Communication
- Design For Six Sigma (DFSS) Certification
- FDA Design Controls
- ISO 13485
- ANSI/AAMI/ISO 14971
- Risk Management
- PDM Enterprise Software
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×