Engineering Technician

Title: Engineering Technician

Division/Department: Engineering

Type of Position: Full Time

Date: March 24, 2025

Job Summary

The Engineering Technician will support the development, testing, and manufacturing of medical devices. This role involves working closely with engineers, quality teams, and production staff to ensure product performance, compliance, and reliability.

Essential Job Duties & Responsibilities

Design and documentation:

• Processes CTO’s (configure-to-order)
• Works with product managers to document new products
• Design of manufacturing jigs, fixtures, and equipment
• Write work instructions
• Create detailed drawings
• Create internal label specifications
• Process document change orders (DCO’s) promptly, accurately and completely
• Perform repairs and preventative maintenance tasks on machinery while keeping detailed records

Performs tasks in a manner that supports Summit Medical agency listings and certifications:

• ISO 13485
• FDA registration

Follow Summit Medical product development process as defined in the Summit Medical Quality System:

• Conducts validation tests and test studies
• Supports first article inspections of new parts and designs
• Supports IQ, OQ, PQ (installation, operation, and process qualifications)
• Supports documentation requirements for Design History File

Interdepartmental relationships and teamwork:

• Assist in equipment setup, calibration, and preventive maintenance
• Provide technical support to production teams for process improvements and troubleshooting
• Helps Production meet company quality standards, cost targets, and production schedules
• Support purchasing with complete documentation as required.
• Provides Sales and Marketing technical support, including help with show samples, prototypes and CAD renderings
• Provides Accounting part cost information as required
• Other duties as assigned.

Education & Experience Requirements

• High School Diploma or equivalent
• Manufacturing process knowledge including: Manufacturing Environment or equivalent
• Strong attention to detail and documentation skills
• Ability to work in a lab, production floor, or cleanroom environment
• Ability to apply learned technology to Company products and processes
• Willingness to learn and apply new technologies
• Software proficiency: Microsoft Outlook, Word, Excel, PowerPoint
• Hands-on approach and desire to troubleshoot equipment and assist in production

Preferred Skills & Abilities

• 2 years of experience in a regulated industry as an engineering technician, test technician, or manufacturing technician role
• Ability to read and interpret technical drawings, schematics, and work instructions
• Computer Skills with: SolidWorks, AutoCad (DraftSight), Adobe Illustrator
• Manufacturing process knowledge including: Molding, injection, transfer molding (silicone), and casting; Metals fabrication; Packaging and labeling; Clean room and sterilization processes
• Product design knowledge design for manufacturing and drafting standards.
• Possess excellent verbal and written communication skills and organizational skills
• Mechanical aptitude with capability to install, assemble, repair and maintain production equipment
• Medical device industry experience beneficial for IQ execution and documentation needs

Working Conditions & Physical Demands

Physical Demands:

• Regularly required to sit, stand, bend, reach and move about the facility
• Perform most manufacturing operations on an intermittent basis
• Climb ladder, lift up to 45 pounds, position as need to construct, repair and maintain plant equipment
• Must be able to fulfill all requirements for cleanroom access
• Microscope work as needed

Working Conditions:

Will perform work in office, on manufacturing floor, and controlled clean room environment. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

We offer a full complement of benefits including health, dental, vision, life insurance, 401(k) and generous PTO. Come work for a growing company that offers a fun, collaborative environment with work-family balance.

Applicants for employment must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).

EOE/Disabled/Veteran

Job Type: Full-time

Pay: $25.00 - $35.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Vision insurance

Schedule:

• 8 hour shift

Application Question(s):

• Do you have any experience in a manufacturing environment?

Experience:

• manufacturing environment: 1 year (Preferred)

Work Location: In person

Salary : $25 - $35