- Designing, implementing, and reviewing the procedures and equipment involved in the manufacturing process. This may include researching controls and automation techniques, testing new systems for efficiency and planning factory layouts to optimize production.
- Leading cross functional projects to improve labor efficiency, optimize product Quality, qualify replacement components, and reduce Manufacturing operating costs through Continuous Improvement Kaizen activities.
- Being adept in resolving and determining root cause of mechanical problems encountered in Production during the Assembly and Testing of products and capable of timely implementing effective solutions.
- Supporting ongoing development and maintenance of Risk Management Reports & Assessments (ISO 14971 standard).
- Supporting site Environmental and Health compliance and personnel Safety activities.
- Leading site and contractor-based maintenance program (preventive and corrective).
- Assisting in Material Review Board activities ensuring proper trending, closure of issues and dispositions are appropriately addressed.
- Supporting manufacturing aspects of design and development of medical devices including compilation, review, and approval of device design history files, risk management reports, coordinate design verification/design validation.
- Supporting ongoing compliance of internal quality system programs including: Management Review, Employee Training, Corrective and Preventive Actions, & Internal quality audits.
- Supporting the generation and maintaining documents including; engineering drawings, labeling, IFUs, etc.
- Other duties as assigned.
- 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/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, PowerPoint.
- Proficiency in AutoCAD system a plus.
- Must pass a drug test and criminal background check prior to starting.
- Day shift
- $75-80k/year - pay is based on experience
- This is a full-time, contract to direct position for the right candidate.