Senior Consumables Engineer

The role

This person will support the design, development, characterization, verification, and validation of product designs and manufacturing processes for disposable medical devices and consumables. They will work on high-volume disposables and consumables using technologies like injection molding, extrusion, and ultrasonic welding.

What you will do

• Uses experience in plastic disposables design, mechanical engineering, assembly techniques and sterilization.
• Creates and translates design concepts into 3D CAD and detailed 2D drawings.
• Owns design development activities from design synthesis through production phase.
• Collaborates with suppliers and Quality Engineering to evaluate manufacturability.
• Selects and specifies materials, off-the-shelf components, and packaging.
• Collaborates with manufacturing engineers to develop assembly processes and product acceptance testing.
• Supports equipment qualification, fixture development, and process automation.
• Contributes to verification and validation testing of components and products.
• Applies statistical methods to analyze data and evaluate process capability.
• Works with Supplier Quality Engineers to validate supplier processes.

Required qualifications

• BS. in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, Industrial Engineering, or related technical discipline.
• 5-7 years of design and development engineering experience in the medical device industry.
• Experience supporting development of disposable medical products.
• Knowledge of process validation methodologies (PPAP, IQ, OQ, PQ).
• Knowledge of medical device quality system requirements (FDA Quality System Regulations, GMPs, and ISO 13485).
• Experience with statistical methods and analysis tools such as Minitab.
• Working knowledge of Design of Experiments (DOE), process capability analysis, and statistical sampling methods.
• Experience with product and process development for assembly in a cleanroom environment.
• Experience supporting manufacturing technologies such as injection molding, ultrasonic welding, assembly processes, leak testing, and sterilization.
• Strong analytical, technical, and problem-solving skills.
• Experience leading and managing engineering projects.
• High level of proficiency on 3D CAD design package, including drafting standards and GD&T.

Nice to have

• Experience in high volume consumables which physically interface with capital equipment.
• Experience working with external manufacturing and molding partners early in the design process.
• Understanding and experience with blood contacting products, including hemodynamics, flow characteristics and material/geometry biocompatibility.
• Understanding of elementary chemistry and biochemistry.
• Six-Sigma Green or Black Belt certified.

About the company

Outset Medical is a commercial-stage company delivering first-of-its-kind technology into the growing dialysis market. Their Tablo Hemodialysis System uses modern technology to reduce the cost and complexity of dialysis.