Sr. Mechanical Design Engineer

Summary

The Senior Mechanical Engineer at Vapotherm is responsible for the design and development of the mechanical systems for durable and disposable products used in respiratory therapy. This individual will use knowledge of the respiratory care environment and customer needs to develop innovative solutions using a disciplined application of mechanics, fluid and heat transfer, material selection, statistical analyses, and DfX principles. He or she will work closely with cross-functional peers in Strategic Initiatives, Marketing, Quality, Regulatory, and Operations while defining and maintaining the mechanical architecture for new devices or sustaining improvements. This individual will stay current with the latest advances in mechanical systems, tools, and technologies and provide valuable input into product designs to ensure Vapotherm stays at the cutting edge of respiratory care innovation.

Primary Responsibilities

• Establish, execute, and communicate product development deliverables within established design control SOPs, Work Instructions, and applicable standards/regulations

• Translate marketing requirements into engineering system and module requirements

• Define the overall mechanical systems architecture for new or changed products and features

• Collaborate with a cross-functional team of engineers to generate and develop design concepts

• Develop mechanical designs using solid engineering and DfX principles

• Apply technical competency towards innovative, complex medical device development

• Develop and document detailed design specifications and acceptance criteria

• Design, build, and test prototypes to prove out design concepts

• Lead and/or support Design, Component and Process FMEAs

• Author & execute verification protocols and reports

• Provide input to manufacturing engineers regarding process development and validation strategy

• Manage projects and coordinate with internal and external partners

• Develop and manage vendor technical relationships to meet cost, quality, and timing goals

• Other duties may be assigned as necessary

Position Requirements

• Bachelor of Science degree in Mechanical Engineering required; minimum 5 years of experience

• Working knowledge of 21 CFR 820, ISO 13485, EN ISO 14971, and IEC 60601

• Strong CAD and simulation tools skills

• Highly proficient with basic mechanics / Machine design, tolerance analysis, and GD&T application

• Experience with plastics material selection and molding, extrusion, and overmolding processes

• Strong statistical and data analysis skills; proficient with software tools to enable analyses

• Excellent communication and writing skills, including technical writing

• Strong interpersonal skills with the ability to collaborate with others in a team environment