Responsible for contribution to the design of products, production fixtures and methods, and testing solutions. Participation in solving technical problems in design, manufacturing, fabrication, inspection, and maintenance. Assists engineers, inspects products, conducts tests, reworks material, and collects data.

Principal Responsibilities

• Act as an engineering resource in transferring new products to manufacturing and sustaining transferred products.
• Develop and document assembly, test, and alignment methods; prepare drawings and visual aids; read, follow, critique, and edit work instructions.
• Assemble fragile and sensitive electro-mechanical and optical medical devices.
• Train manufacturing staff on assembly methods/procedures.
• Conduct experiments and record data in a laboratory environment; perform data analysis.
• Collaborate directly with engineers, production operators, quality inspectors and management personnel.
• Communicate technical issues clearly and effectively to engineering staff.
• Establish and maintain stability of late-stage development programs and build activity.
• Maintain adequate inventory of all laboratory supplies (e.g., epoxies, Q-tips, etc.).
• Understand and comply with the company’s quality system; support compliance with FDA QSR, ISO 13485, and other regulatory requirements.
• Perform miscellaneous duties and projects as assigned and required.

Training, Skills, Knowledge and/or Experience

• 3 years’ experience in a manufacturing, development, or engineering environment with precision devices; background with optics, electronics and/or other small, delicate, or sensitive products.
• Strong mechanical and general software aptitude. Ability to quickly learn new technologies and tools.
• General understanding of data collection, data reduction, and statistics.
• Experience working in FDA QSR and ISO 13485 environments preferred.
• Experience interfacing with quality, stockroom, production control, purchasing, and engineering personnel.
• Working knowledge of Microsoft 365 apps suite, basic use of ERP/MRP systems.

Education Requirements

High School Diploma or GED required. Associate, two-year technical degree, or equivalent level of education preferred.

Supervisory Responsibility

No supervisory responsibility.

Working Conditions

This job operates in manufacturing and engineering laboratory environments including ISO class 7 cleanrooms.

Physical surroundings

This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. PPE required when in controlled environment rooms.

Physical Effort

While performing duties of this job, the employee is regularly required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear.

Travel

Limited, infrequent travel may be required.