Medical Device Embedded System Engineer Jobs in Connecticut

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:

• Operates and programs advanced measurement equipment including Vision Systems, CMMs, PLCs, Optical Sensors, Contractors, 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 TOMZ’s 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.

• Adhere to the TOMZ Quality Management System.

• Perform other duties as assigned.

Qualifications:

• Demonstrated self-starter with ability to work in a fast-paced environment.
• Competency with Microsoft Office
• Strong verbal and written English language communication skills.
• Basic understanding of statistical techniques and sampling strategies

Experience:

• Minimum of 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.
• 3+ years training in GD&T and measurement programing system.

Education:

• High School Diploma or GED

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).

Travel Requirements:

• Travel outside of the workplace is required for up to 5% of the year.
• Travel may include multiple overnight stays and may occasionally require weekend commitments.

Physical Requirements:

• Ability to bend, stoop, squat, kneel, and lift up to 30 pounds. Team lift or mechanical assistance required for objects over 30 pounds.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Ability to sit for prolonged periods.
• Proficient use of a keyboard and mouse, requiring manual dexterity and coordination.
• Ability to focus on a computer screen and other visual tasks for prolonged periods, with appropriate vision correction if needed.
• Perform repetitive hand and arm movements.