Assembler I

Route 92 Medical; West Jordan (UT); On-site; USD 42,000 - 58,000; Full time

Benefits offered by this job

Comprehensive healthcare benefits

Corporate bonus program

Generous PTO and 16 holidays

12 weeks parental leave

Monthly cell phone stipend

Job summary

Route 92 Medical is seeking a Manufacturing Operations Support role at our West Jordan facility. The on-site shift runs Monday–Friday 6:00am–3:00pm with one Saturday per month.

Responsibilities include line setup, production assembly, coating operations, and material handling to support manufacturing KPIs. Applicants should have at least 3 years of medical device manufacturing experience, a high school diploma, and knowledge of GDP, GMP, and ISO 13485.

Qualifications

• High School diploma or equivalent.
• Minimum of 3 years of work experience in medical device manufacturing (dexterity test).
• Experience with GDP, GMP and ISO 13485 regulatory requirements is preferred.

Responsibilities

• Assemble and test products per MPI/Work Instructions and STM.
• Document Lot History Records and manufacturing forms accurately.
• Maintain workstation, adhere to CER requirements, and operate equipment.
• Identify non-conforming units and communicate issues to management.
• Provide feedback for process and product improvements.
• Support calibration and preventive maintenance for equipment.

Skills

GDP/GMP knowledge

ISO 13485 knowledge

Lean manufacturing

Attention to detail

Teamwork

Communication

Education

High school diploma

Tools

Caliper

Microscope

Hot box

Laminator

Coil winder

Pouch sealer

Job description

About Route 92 Medical

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention. At the core is a reconsidered procedural approach, cutting-edge engineering, and innovative product design. Our portfolio targets the most significant challenges in neurointerventional care to deliver meaningful solutions. The company was founded by physicians developing thoughtful product solutions in collaboration with the world’s leading clinicians, who focus on improving procedural and patient outcomes.

About Route 92 Medical

Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention. At the core is a reconsidered procedural approach, cutting-edge engineering, and innovative product design. Our portfolio targets the most significant challenges in neurointerventional care to deliver meaningful solutions. The company was founded by physicians developing thoughtful product solutions in collaboration with the world’s leading clinicians, who focus on improving procedural and patient outcomes.

https://www.route92medical.com/

Chart a new course

Route 92 Medical is looking for dynamic, innovative people who are inspired by our mission to improve outcomes for patients undergoing neurovascular intervention.

We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others. Teamwork matters here. We are committed to collaboration and finding innovative solutions that advance neurovascular intervention, establishing Route 92 Medical as one of the premier companies in the field.

Purpose Of Job

• Provides the manufacturing operations team with cross-functional support, with a primary focus on manufacturing key performance metrics.
• Daily tasks may include line setup, training, production assembly, coating operations, engineering runs, and material handling.
• This role is onsite in our West Jordan manufacturing facility and the schedule is Monday-Friday 6am - 3pm and 1 Saturday a month.

Responsibilities

• Uses hand tools, fixtures, and equipment to assemble and test products per Manufacturing Process Instructions (MPI), Work Instructions, and Standard Test Methods (STM)
• Accurately documents the record of work on the Lot History Record (LHR) and manufacturing forms
• Sets up and maintains workstation; adheres to CER (Controlled Environment Room) requirements
• Operates production equipment such as hot box, laminator, and coil winder
• Performs visual inspection and uses basic measuring tools such as a caliper and a snap gage
• Identifies units that are non-conforming and notifies management
• Provides feedback to management and engineers regarding process and product improvements
• Problem-solving manufacturing-related issues
• Maintain manufacturing equipment in compliance with Calibration and Preventive Maintenance requirements. Support Equipment maintenance and qualifications, as needed
• Available to work overtime one Saturday per month at a minimum
• Other duties as assigned

Skills For Success

• Ability to read and speak English (i.e., read and understand manufacturing procedures)
• Experience and knowledge of GDP and GMP practices and ISO 13485 regulatory requirements
• Effective communication, interpersonal, and team skills
• Excellent attention to detail and organization
• Basic understanding of Lean Manufacturing concepts (Flow, 5S, Line Balance)
• Knowledge of the commonly used concepts, practices, and procedures within the medical device industry.
• Ability to use microscopes, tweezers, razor blades, pliers, and other handheld tools for small parts.
• Proficiency with the use of equipment such as hot box, adhesive dispenser/cure, laminator, coil winder, and pouch sealer

Required Education

• High School diploma or equivalent

Required Experience

• Minimum of 3 years of work experience in medical device manufacturing (there will be a dexterity test)

Benefits & Perks

• Comprehensive healthcare benefits are effective day one! R92M offers generous benefit options, including Medical, Dental, Vision, Life Insurance, FSA, HSA, Short-term and Long-term disability, Critical Illness Insurance, and Accident Insurance.
• Competitive base pay plus corporate bonus program
• Generous paid time off and 16 paid holidays, including a company-wide summer recharge week in July
• 12 weeks of paid parental leave for employees after 90 days of employment
• Monthly cell phone stipend

The actual base pay is dependent on several factors, including, but not limited to, work experience, market data, skills, geographic location, and business needs. The base pay range is subject to change and may be modified. This role may also be eligible for equity.

Monday - Friday 6:00am -3:00pm plus 1 Saturday OT a month