JOB SUMMARY

This position is primarily responsible for developing and improving assembly operations to improve productivity, yields and process flow. Must provide excellent troubleshooting ability on equipment and assembly fixturing. Will assist Manufacturing Engineering with developing new processes, documentation, performing experiments and developing tooling/fixturing as needed

ESSENTIAL RESPONSIBILITIES

• Complies with all Good Manufacturing Practices (CGMP) requirements to ensure products are controlled according to the Quality System
• Writes and edits technical documents including reference manuals and product manuals
• Translates customers’ technical specifications into work instructions for the direct labor staff that will enable them to follow with little to no training
• Works with engineers, programmers, and project managers to ensure safe reliable delivery of final product to the customer
• Research new processes and equipment that improves line efficiency
• Meets internal and external customer deadlines
• Works with Engineering, customer representatives and manufacturing personnel in problem solving exercises.
• Works with Maintenance personnel to incorporate equipment PMs
• Works with drawings to interpret nomenclature and dimensions
• Operates effectively and maintains professionalism in an environment of deadlines and high workloads and adjusts schedule or work hours to meet changes in priorities
• Assists with processes and documentation for new or modified products
• Actively participates in improving quality and processes for the products we manufacture
• Acts as a resource during audits or customer visits for questions and answers or practical demonstrations
• Supports required equipment qualification and process validations (IQ, OQ and PQ)
• Is a key trainer for employees on new processes and products being transferred from Engineering to Production
• Assists Engineering with improving quality and solving problems
• Designs fixtures and gauges
• Processes basic ECO’s to existing drawings, tooling, and fixtures
• Dispositions Non-Conformance Reports (NCR’s)
• Complies with company, quality and safety standards, policies, and procedures
• Other duties as assigned

This is not a remote position.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

QUALIFICATIONS

• 2+ years of engineering technical experience in a medical manufacturing environment, or equivalent Associate degree or equivalent experience in medical device industry a plus
• Hands on experience working with equipment
• Knowledge of manufacturing and assembly processes
• Advanced equipment troubleshooting experience
• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Experience with continuous improvement activities
• Ability to meet deadlines and to work independently.
• Proficient with Microsoft Office Suite or related software
• Must be able to read, write and speak fluent English
• Basic understanding of Lean Concepts
• Ability to learn and apply new technology
• Able to prioritize and manage multiple responsibilities
• Basic working knowledge of blueprint and geometric tolerances
• Ability to diagnose and solve problems with jobs in a timely manner
• Validation experience
• Technical report preparation experience

WORKING ENVIRONMENT

Work is performed in a manufacturing and office environments. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.