Senior Mechanical Engineer

The Senior Mechanical Engineeris responsible forsystem level designs and prototype fabrication of the hardwareportionon our FDA Class II registered AAC devices. The senior mechanical engineerutilizesa 3D CAD platform (SolidWorks), which includes solid modelingand surface modeling, assembly modeling, and 2D drawing development to meet the program requirements and needs of our device users.

The senior mechanical engineer willcollaborate with other mechanical engineers, industrial designers, electrical engineers, product managers, project managers,QA/RA, sourcing andsuppliers, as well as our manufacturing group in China to ensure program design activities, goals and targets are completedon-time, on budget, to ensure a successful product. A key emphasis is the ability to contribute to a fast-paced development team to bring engineering solutions from concept through production to give our customers a voiceutilizingour AAC devices.

Responsibilities and Accountabilities:

• Conceptual and detailed design of molded components (plastic and metal), sheet metal and machined components.

• Generateparts, assemblies, and drawingsusingSolidWorks.

• Develop innovative solutions that support the project requirements.Hands on prototyping and proof of concept.

• Work as part of a team of mechanical and manufacturing engineering staff to bring projects through prototyping and into production launch.

• Perform and present gated design reviews with both internal staff and external vendors at specific times in the design life cycle of an AAC device. -     Participate in the ECO process and support change management.

• Develop BOMsand part numbers in ourQMSsystem.

• Risk management

Who we are looking for:

Minimum Education and Experience

Bachelor’s Degree in Mechanical Engineeringand 5-10+ years relevant work experience developing complex plastic/metal injection molded components that can be tooled and molded. Electronics hardware development experience preferred.

Required Skills and Education: 

• Experience with detail part/assembly/drawing development is required

• Experience with design formanufacturabilityand assembly isrequired

• Proficientutilizing SolidWorks

• Proficient in complex 3D solid and surface modeling

• All Microsoft Officesoftware andTeams

• Great problem solving and communication skills

• Experience being part of a high-performance team in a fast-paced environment

• Ability to maintain a safe working environment
  

Preferred Skills and Education:

• Background in FDA registered Class II medical devices

• AnunderstandingofISO 13485 standardsand IEC60601

• Experience with AAC devices

• ExperiencewithCAD PDM data management andArena or similar QMS system

• Plastic injection molding tool development

• Collaborating with a world-wide team (USA, China, Sweden)