Position Summary:

Support operations to ensure the highest quality and lowest cost products are built as scheduled. Provide Mechanical Engineering expertise to support current manufacturing line and to prepare Manufacturing line for next generation of product by creating fixturing and automation for new production line. Provide mechanical engineering expertise in the design of next generation systems and designs to resolve manufacturing and supply issues. Suggest and evaluate design changes to improve product reliability and manufacturability. Assist with technical customer support. This position requires someone who is enthusiastic, self-directed, effectively leads cross-functional teams, and is capable of becoming a system level product expert.

Essential Functions:

Engineering

• Provide engineering expertise to the miraDry Operations team
• Design of next generation components and assemblies.
• Work with and manage external vendors on next generation designs
• Identify and oversee outside suppliers and consultants as required
• Drive projects to timely completion in support of corporate objectives
• Develop fixtures to reduce assembly variability and to test components/sub-assemblies

Production

• Develop and design manufacturing test systems for next generation product.
• Develop and improve existing manufacturing processes to minimize rework and reduce cost
• Conduct process validations and equipment qualifications
• Develop clear and concise documentation including manufacturing procedures, work instructions, protocols and reports, BOMs and travelers
• Troubleshoot and document any product issues that arise during assembly and test.
• Respond to “line down” situations; work with assemblers and technicians to resolve issues.
• Ensure timely closure of Non-Conformance investigations - implement corrective actions, identify root cause, and implement preventive actions

Technical Customer Support

• Provide support in the resolution of product complaints and/or safety issues.
• Diagnose field failures, identify root cause, and implement corrective action.
• Troubleshoot returned systems (RMAs) and document rework process.

Comply with miraDry’s quality system requirements as well as any applicable regulatory requirements.

Comply with all health and safety regulations, policies, and work practices.

Perform other duties as assigned.

Education and Experience:

• BS degree in Mechanical Engineering
• 5 years relevant experience required with at least 3 years in medical device industry preferred
• Candidate must have and demonstrate Solidworks experience
• Experience with LabVIEW, Python, LabWindows, SQL, and/or MATLAB a plus
• Candidate must have strong troubleshooting skills
• Experience with Mechatronics, Audruino, Raspberry Pi, or RF/microwave based products a plus
• Machining skills a plus

*Salary is dependent on experience

FLSA Status: Exempt