Manufacturing Engineer
8170 Embury Rd Grand Blanc, MI 48439 US
Job Description
Manufacturing Engineer
What we value
- Integrity. We do what is right.
- Accountability. We do what we say.
- Customer First. We deliver extraordinary experiences.
- One Global Team. We before me, always.
- Inspired. We love what we do.
What you will do
- Responsible for designing, implementing, and reviewing the procedures and equipment involved in the manufacturing process. Their duties include researching controls and automation techniques, testing new systems for efficiency and planning 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.
- Be 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.
- Support ongoing development and maintenance of Risk Management Reports & Assessments (ISO 14971 standard).
- Support site Environmental and Health compliance and personnel Safety activities.
- Lead site and contractor-based maintenance program (preventive and corrective).
- Assist in Material Review Board activities ensuring proper trending, closure of issues and dispositions are appropriately addressed. 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, coordinate design verification/design validation.
- Support ongoing compliance of internal quality system programs including:
- Management Review
- Employee Training
- Corrective and Preventive Actions
- Internal quality audits
- Support the generation and maintain documents including; engineering drawings, labeling, IFUs, etc.
- Other duties as assigned.
What you will need
- Bachelor’s degree in an engineering discipline.
- Minimum of 2 years or 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.
- 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.
Pay Rate Range: $40-$60/hr. Salary will be dependent on experience
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