Description

The Senior Manufacturing Engineer works to Improve the efficiency of Production through the Design, Implementation, Maintenance of equipment, procedures, and systems. This role is critically involved in the entire product lifecycle.

Essential Job Duties and Responsibilities:

• Serve as a Subject Matter Expert in the production of electro-opto-mechanical medical devices
• Responsible for design transfer to manufacturing for legacy and new products
• Engage with production team and assist with all aspects of production from receiving/inspection, assembly, troubleshooting, and final test
• Interface with design engineers to ensure product development meets manufacturing expectations and processes.
• Develop and implement manufacturing and assembly processes using manual, semi-automatic, and automated tools.
• Work closely with Engineering, Manufacturing, and Quality Assurance Departments to review manufacturing and assembly processes for sustaining and future products.
• Identify and solve manufacturing related problems, implement changes to manufacturing and assembly processes with proper regulated change control.
• Review and coordinate introduction of new designs, processes, and components from Engineering into Manufacturing.
• Estimate costs, determine time standards, and make recommendations for tooling and process requirements of sustaining or existing product lines.
• Oversee transfer of designs and processes to contract manufacturing to ensure quality manufacturing.
• Design tooling and fixturing for assembly
• Manage quality validation processes including IQ, OQ, and PQ testing of automated processes
• Conducts or participates in audits of contract manufacturers
• Ensures product and process meet quality and design specifications by testing First Articles
• Coordinates incoming inspections on manufactured components
• Assist QA in the CAPA process

Required Knowledge and Skills

• Bachelor’s degree in Manufacturing/Mechanical/Electrical/Industrial Engineering; or equivalent experience
• Minimum 8 years' hands-on experience in manufacturing, manufacturing process, and design for manufacturing
• Experience working in medical device environment
• Fluency with MCAD (SolidWorks), MRP (NetSuite), Microsoft Office Suite (Word, Excel, PowerPoint)

Desired Knowledge and Skills

• Experience with automated assembly processes, including general software knowledge or experience with programming motion control systems
• Experience generating manufacturing documentation such as work instructions
• Experience troubleshooting Electronics/Software in testing systems
• Experience with FDA Part 21 and ISO 13485 regulations for manufacturing practices
• Participated in external and internal audits to ensure compliance
• Manufacturing of optical/photonic assemblies
• Experience with fiber optics
• Experience in process and equipment qualification/validation
• Experience in using statistics and statistical process control (SPC) to make data-driven decisions while driving improvements
• LEAN or Sigma Six certification

Physical & Environmental Requirements:

• Fast-Paced, high-volume office and production environment with frequent interruptions
• Proficient use of office equipment
• Will be expected to travel up to 25% of the time
• Ability to sit and stand for extended periods of time
• Ability to lift 25 lbs

Zynex Offers Exceptional Benefits (Full-Time Roles):

• Premium starting pay.
• Health, dental, & vision insurance.
• 401k with company contribution.
• 8 paid holidays
• Zynex Prime PTO Program
• Health & wellness bonus up to $50/month.
• Frequent opportunities for role transitions and advancements.
• Weekly employee appreciation activities/perks.
• Up to $75/month reimbursement for community volunteer hours.
• Employee product discounts.

In order to be considered for this position, applications must be submitted by 05/21/2024

To view and apply for all available positions at Zynex, kindly visit our careers page at www.zynex.com/careers.

Zynex Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Zynex Medical remains vigilant against fraudulent schemes, including the use of deceptive tactics like text messages and forged letters, which falsely promise job interviews and/or offers of employment under our company's banner. To clarify further:

• We are actively hiring for various positions and will never ask for payment for job placements.
• Job openings are solely advertised on trusted platforms like Indeed.com, LinkedIn.com, and Zynex.com.
• Be cautious of job interview invites from locations other than our corporate office at 9655 Maroon Circle, Englewood, CO 80112.
• Requests for information, interview scheduling, and job offer letters are validated exclusively if they originate from a sender's domain identified as zynex.com.
• Report any recruitment approaches not linked to our official advertisements to law enforcement promptly.

Qualifications