Manufacturing Engineer, Ophthalmology

At Corza Medical, our mission is to champion surgical providers with remarkable service and exceptional products that save time, money, and effort. We are a passionate team guided by our core belief that you should never have to choose between performance, value, and a quality customer experience.

About the role

We are seeking a Manufacturing Engineer with an engaging and generous spirit who excels in a dynamic, growth-oriented environment to join our team. The candidate will lead aspects pertaining to safety, quality / customer satisfaction, delivery, and operational efficiency within a medical device manufacturing facility.

Responsibilities

• Design, implement, and review the procedures and equipment involved in the manufacturing process.
• Research controls and automation techniques, test new systems for efficiency, and plan factory layouts to optimize production.
• Lead cross-functional projects to improve labor efficiency, optimize product quality, qualify replacement components, and reduce manufacturing operating costs through Continuous Improvement Kaizen activities.
• Resolve and determine root cause of mechanical problems encountered in production during the assembly and testing of products; implement effective solutions in a timely manner.
• Support ongoing development and maintenance of Risk Management Reports & Assessments.
• Major contributor within site Environmental and Health compliance and personnel safety activities.
• Lead site and contractor-based maintenance programs (preventive and corrective).
• Assist in Material Review Board activities ensuring proper trending, closure of issues, and appropriate dispositions; drive continuous improvement initiatives based on MRB data.
• Support manufacturing aspects of design and development of medical devices including compilation, review, and approval of device design history files, risk management reports, and coordination of design verification/validation.
• Support ongoing compliance of internal quality system programs including: Management Review, Employee Training, Corrective and Preventive Actions, and Internal quality audits.
• Generate and maintain documents including engineering drawings, labeling, IFUs, Work Instructions, etc.
• Other duties as assigned.

Requirements

• Minimum of 2-4 years’ experience in direct engineering support of quality management systems for medical device & biologics development and manufacturing of sterile devices (US & EU class I, II devices and tissue products).
• Solid working knowledge of FDA Quality System Regulation (21 CFR 820) and ISO 13485-2016.
• Bachelor’s degree in an engineering discipline.
• Experience in process engineering/validation/test method development.
• Excellent organizational and record-keeping skills.
• Ability to clearly communicate information, ideas, and recommendations (verbally and in writing) with technical, administrative, and management personnel.
• Moderate controls and automation experience.
• Proficiency in information technology applications such as MS Word, Excel, and PowerPoint.
• Proficiency in SolidWorks and Labelview; AutoCAD is a plus.
• Root cause analysis and problem-solving skills.
• Lean / Six Sigma certification is a plus.
• Applicants must be authorized to work for ANY employer in the US; sponsorship is not available at this time.

Benefits

• Competitive benefits package including medical, 401K, vacation and sick time, and paternal leave.

Pay

A reasonable estimate of the current pay range for this role is $75,000 - $85,000/annual. Pay is offered based on geographic location, internal equity, market data, applicant’s job-related skills, commensurate experience, required licensures, certifications, and certain degrees.

Corza Medical is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, marital status, religion, sex, sexual orientation, gender identity, age, national origin, physical or mental disability, veteran status, or other protected characteristics.