Vision System Programmer

Our client, a leader in the manufacturing of devices and components for major medical device companies, is looking for a Metrology Specialist to join their organization. They offer competitive compensation and excellent benefits, including 401k, health/dental, vision, and paid time off. They maintain a modern, clean, and safe facility with state-of-the-art equipment and dedication to continuous improvement. The company is registered with the FDA Medical Device Manufacturer and is certified to ISO 13485.

SUMMARY OF POSITION:

This position will be responsible for the activities associated with developing advanced metrology methods in a medical device manufacturing environment. This includes but is not limited to assessing process risk and implementing appropriate control mechanisms, corrective / preventative action, and creating and refining test methods

ESSENTIAL FUNCTIONS:

• Must be knowledgeable of, and adhere to, the company Quality Management System.
• Operates and programs advanced measurement equipment including Vision Systems, CMMs, PLCs, Optical Sensors, Contracers and Laser Measurement Systems.
• Acts as the Subject Matter Expert in GD&T.
• Uses expertise in bench layouts to resolve complex measurement challenges.
• Collaborates and defines Test Method.
• Expertise of precision measuring instruments and their application, including but not limited to, electronic height gages, calipers, micrometers, depth gages, indicators, and plug and thread Go/No Go gages.
• Execution and evaluation of Test Method Validations.
• Support the creation of production visual standards and standardized acceptance criteria for the companys manufacturing processes.
• Design, Model and Build inspection work holding fixtures.
• Provides hands on direction for executing Incoming, In-Process and Final Product Inspection plans.
• Champion First Article Inspections.
• Support Gage calibration review, management, execution and evaluation.
• Establish standards for Gage Calibration.
• Competency with materials testing chemistry and mechanical testing.
• Support and enforce Quality Best Practices and GDP/GMP continuous improvement efforts.
• Support the tracking and reporting of inspection data, including but not limited to rejection rates, defect modes and process trends across customers/product families.
• Reviews ECOs for the release of Quality Engineering documentation.
• Creates inspection instructions.
• Other duties and responsibilities as assigned.

QUALIFICATIONS:

Education/Experience

• Technical training in GD&T and measurement programing system.
• Minimum of 0-4 years experience in a regulated manufacturing environment.
• Minimum of 3 years of manufacturing quality experience including advanced metrology experience including CMM and/or Vision System programming.

Qualifications

• Ability to travel up to 5%.
• Demonstrated self-starter with ability to work in a fast-paced environment.
• Competency with Microsoft Office (i.e. Outlook, Word, Excel, and PowerPoint)
• Strong verbal and written English language communication skills.
• Basic understanding of statistical techniques and sampling strategies

Preferred skills

• ASQ-CQT, CQE or CRE preferred.
• Certifications in DMIS programming preferred.
• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g. Aerospace, Defense, Pharmaceutical, etc.).
• Knowledge and experience with external standards: ISO 900/9001, ISO 13485, and 21CFR 820, EU MDR, especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints).

Physical Demands

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Retirement plan

Schedule:

• Monday to Friday

Application Question(s):

• Are you able to operate and program advanced measurement equipment including Vision Systems, CMMS, PLCs, Optical Sensors, Contracers and Laser Management Systems?
• Are you able to execute and evaluate Test Method Validations?
• Do you have experience and are proficient with GD&T?
• How many years of work experience do you have with Microsoft Excel?
• Will you now, or in the future, require sponsorship (i.e. H-1B visa, etc.) to legally work in the U.S.?
• A requirement for this role includes proficiency in English, both written and spoken. Do you meet this requirement?
• What hourly rate are you targeting?
• If offered the position, are you willing to undergo a background check and drug screening, in accordance with local laws and regulations?

Work Location: In person