Senior Mechanical Engineer (Composites)

Company: Calypso Medical
Job Location: Seattle, WA

About The Position
Calypso® Medical is looking for an individual who will be responsible for design of a complex electromechanical assembly for a portable medical device, design validation testing, manufacturing tool design, and process development for these assemblies. This individual will also work with several outside vendors that will include the development of a proprietary lamination process and in-house electrical engineers regarding all electrical components and subassemblies.
1. Responsible for the mechanical design of the electromechanical assembly to ensure all requirements are met. Design and development responsibilities will extend from functional prototypes through design transfer.
2. Will play a key role in the manufacturing processes required to fabricate the electromechanical assembly and development of mechanical test methods required for evaluation.

Responsibilities
Responsibilities include but are not limited to:
1. Create multi-layer assembly models, generate drawings, procure and test prototypes, and optimize designs as needed.
2. Work with outside vendors to design for manufacturability, develop custom tooling and manufacturing processes, and resolve production issues.
3. Select appropriate materials based upon functional requirements and cost.
4. Prepare drawings, test reports, presentations, and participate in design reviews.
5. Create drawings and drawing changes per Calypso Medical’s document control procedure.
6. Develop test methods and protocols, design and procure test fixtures, test prototypes, prepare reports and coordinate with outside test facilities as needed.
7. Work with the project team to investigate problems, conceive possible solutions, and implement changes.
8. Work with marketing, engineering, and customers on industrial designs concepts for the product.
9. Work with quality to ensure all medical device safety requirements are met.
10. Work with marketing to define product requirements.

Qualification Requirements
1. Minimum 8 years engineering experience in a product design, development, and manufacturing environment.
2. B.S. degree in Mechanical Engineering is required.
3. SolidWorks experience is required.
4. Experience with several of the following processes is required. Multi-layer laminations, injection molding, insert molding, and CNC machining.
5. Experience with several of the following materials is required. Thermoplastics, structural foams, epoxy adhesives, rigid and flexible PCB's, and PCB materials including FR-4 and high performance laminates.
6. Previous experience bringing new products to market through the complete product development cycle.
7. Excellent written and verbal communication skills.

Preferences
Candidates should have:
Experience in medical device design and development.
Experience with FDA requirements for Class II and Class III medical devices.
Experience with IEC 60601-1 for medical devices.
Experience developing, implementing, and validating manufacturing processes including tool design.
Experience with PDMWorks, COSMOS (stress and displacement and heat transfer analysis), and MatLab.
Experience with mechanical and/or optical CMM.
Industrial design skills and ability to work productively with marketing and engineering.

Principals Only. Please email your resume/CV to Andi Levin at alevin@calypsomedical.com.