If you are a qualified candidate and would like to be considered for the following position please submit your resume to Human Resources and specify the posted job code.
Assembler (Level 2-3)
The Assembler (Level 2-3) will assemble plastic and metal components into high quality medical devices in accordance with approved manufacturing procedures, perform in-process quality checks on sub-assemblies and finished product, utilize small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
Additional duties will include maintaining accurate records/documentation related to quality, work in progress, test results, and working with engineers and technicians to resolve line issues and suggest improvements.
Must have a high level of hand-eye coordination and manual dexterity to work with small plastic and metal components in a big volume manufacturing setting. Must have ability to read, write, and comprehend English. Must have ability to utilize math skills. Must not have any medical conditions that would prevent work in a Controlled Environment Room.
For a Level 2 Position must be a High School graduate, with one-year prior assembly experience. Proficient in basic assembly procedures.
For a Level 3 Position must be a High School graduate, with two years prior assembly experience. Cross-trained in two or more product areas.
Job Code: 112-005-10
Quality Systems Manager
The Quality Systems Manager will effectively manage the company’s quality assurance function to meet company objectives. Responsibilities will include: strategic quality system insight and direction, quality systems management, management of the Quality Systems Group, and the handling of budgeting issues. In addition, the QS Manager will provide ongoing support of continuous improvement projects. Further duties will include managing IRIDEX’s complaint system, CAPA system, Document Control and managing and planning internal and supplier audits. The QS Manager will be responsible for Annual Reporting and domestic registration & licensing and will ensure the integrity of key Quality System elements.
Must be an effective team player interfacing well with R&D, Engineering, Manufacturing, Marketing and Sales. Requires a Bachelor’s degree or equivalent and 8 years of progressive responsibility with at least 4 of those years in the medical device industry in a Quality System/Quality Assurance and/or Regulatory capacity.
Job Code: 250-009-010
Manufacturing Engineer
The Manufacturing Engineer is the key person to support Manufacturing, and assist Operations with the alignment and testing of medical lasers, delivery devices, disposables and accessories. He/she will be expected to perform complex mechanical alignment and electronic calibration of test fixtures and consoles; create ECR’s and Process Deviations as required; and perform implementation of ECO’s into manufacturing.
The candidate will provide training to manufacturing personnel on assembly and test of medical laser products. The Manufacturing Engineer needs to be able to resolve problems that relate to product manufacturing and repeatability; prepare written reports and recommendations for procedural changes, and to improve processes, document those processes and write procedures.
The person in this position will set-up calibration and verification of equipment including preventative maintenance as required. This person will also develop test fixtures for manufacturing and contracted suppliers. Further responsibilities include generating IQ, OQ test reports for new equipment and test fixtures, and operate standard test equipment relating to medical laser products. He/she will recognize failures and troubleshoot the problems, (electronic, optical and/or mechanical). Provide technical assistance to customers, sales and other technical personnel in manufacturing.
The Manufacturing Engineer will make recommendations to purchasing for alternative manufacturers to reduce cost, while meeting IRIDEX specifications; provide support for new product introductions; and help assure smooth transitions of new product from R&D into manufacturing by reviewing all relevant documentation, procedures, and training requirements. Responsibilities as a key MRB member includes signing all rework NCMR’s and coordinating the disposition of all in-process failures and resolutions.
The candidate will manage Corrective Action Reports as required, getting to root cause and working with Quality and Suppliers for appropriate resolution and closure. Will maintain Parts and BOM’s in company ERP system, and will
maintain CAD drawings as required in various CAD systems (and/or coordinate drawing changes with Design Engineering).
This is a mid-level position and requires use of judgment and technical training.
Requires a BS degree or equivalent in mechanics, electronics, optics, or equivalent discipline, and/or 5 years experience; the ability to communicate with others clearly, written and oral. Requires knowledge of analog and digital circuitry (and/or experience with), laser technologies and optics The ability to read and understand technical manuals, schematics, prints and procedures is vital. Must have the ability to assess problems and provide problem-solving techniques. Requires knowledge of manufacturing assembly, alignment and test with respect to development of process and procedure development. No medical conditions preventing work in a Controlled Environment Room. CAD experience desired. ERP experience maintaining parts and BOM’s.
Job Code: 111-006-11
Please send resumes to hr@iridex.com