Job Title: Mechanical Engineer
Level: Depends on experience
Department: Research, Development, and Multi-Disciplinary Engineering
Reports To: Vice President/CTO

SUMMARY:
This position requires a senior Mechanical engineer with a strong background in CAD software and at least five years of experience designing with SolidWorks or Fusion360, CAD designs for 3D printing, prototyping, and industrial manufacturing. In this role, the senior mechanical engineer will ensure compliance with FDA guidance, generate technical documentation such as CAD drawings and specifications, and conduct failure mode effects analysis (FMEA) to ensure that iCRx products are safe and effective.

The candidate will maintain regulatory and quality compliance throughout the mechanical and industrial designs and product development lifecycle. The mechanical engineer will provide quality leadership for hardware development projects involving design, modeling, prototyping and manufacturing, production, and post-market support. The work focuses on research, development, and manufacturing of medical devices. Such duties will include but are not limited to developing and maintaining Design History files, Device Master Records, interface control documents, continuously improving designs and processes to enhance product performance and reduce costs, and working collaboratively in a team of multidisciplinary members, including industrial designers, optical, electrical, and software engineers, quality assurance, regulatory consultants, and marketing and providing clear instructions to the project team, clearly explaining the hardware design and integration to the customer, and being available to answer any questions that may arise using exceptional communication skills.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Must have advanced understanding of at least two CAD software such as SolidWorks, Fusion360, etc.
• Create mechanical designs and apply engineering knowledge and skills as a technical engineer during all design and development phases.
• Design and develop hardware test procedures and functional qualification test requirements and procedures.
• Manage external relationships involving product design and manufacturing.
• Participate in risk management activities and implement risk mitigation strategies.
• Participate in hands-on fabrication and testing of prototypes using bench testing and recommend and implement design modifications.
• Detail and organizational skills
• Exhibit a strong “quality first” mentality and ensure that hardware and product quality are held to the highest standard.
• Engage in technical planning, design, and design reviews of several hardware configurations.
• Demonstrate interactive problem-solving skills to coordinate resources, technical issues, and external consultants.
• Comfort with working in a dynamic and innovative environment with significant demands on new product introduction
• Desire to teach and willingness to learn

To apply, send your resume to jobs@icrxinc.com

Job Title: Assembly Technician
Level: Depends on experience
Department: Research, Development, and Multi-Disciplinary Engineering
Reports To: Vice President/CTO

SUMMARY:
This position requires an Assembly Technician with a High School diploma or BS degree in a technical field and 3 to 5 years of previous experience in a medical device manufacturing environment or similar industry. In this role, the candidate will manually assemble optical parts/systems, electronic components, and other sub-system assemblies into workstations and medical devices. The technician will continuously inspect sub-assemblies and components for quality during the assembly process and document their processes. The candidate will ensure that regulatory and quality compliance is maintained throughout the assembly and at completion. Working collaboratively in a team of multidisciplinary members, including industrial designers, optical, electrical, mechanical, and software engineers, quality assurance, regulatory consultants, and marketing. Reporting to the project team, clearly explaining how the assembly and integration are completed, and being available to answer any questions that may arise using exceptional communication skills.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Work directly with project leads to build pilot production quantities of new products following written and demonstrated procedures and conduct testing of products and components.
• Produce small, assembled parts according to verbal and written procedures.
• Assemble optical and mechanical components, integrate electrical components, test, and document all systems and sub-systems for production.
• Ensure all products are built and tested according to documented procedures, and all forms are completed correctly.
• Operate adhesive dispensers, tipping machines, drilling, punching, and measuring devices to assemble parts.
• Support receiving returned products, verifying and investigating the product, and determining repair costs.
• Maintain confidential information in accordance with iCRx policy.
• Adhere to safety requirements.
• Comfort with working in a dynamic and innovative environment with significant demands on new product introduction.
• Desire to teach and willingness to learn.
• Produce and adhere to the completion schedule.
• The candidate will strongly advocate for hardware quality at all stages of product realization.

SUPERVISORY RESPONSIBILITIES:
The candidate will have to work within a team of people across different functions. Direct supervision of others is not needed. Excellent communication skills across different levels of skills and education are expected. Candidate must be comfortable with a high-pressure environment, able to work with minimal supervision, and be a quick self-starter.

JOB REQUIREMENTS:

• High school diploma or BS in a technical field such as mechanical, electronics, or optics
• Minimum of 3 years of experience in Class II medical device assembly
• Laboratory and experimental hands-on skills
• Excellent communication skills across all functions and levels of education
• Excellent documentation practices
• Strategic thinking and Problem-Solving Aptitude
• Fluent in written and spoken English

To apply, send your resume to jobs@icrxinc.com