Manufacturing Engineer - Local applicants

　　Location of Work Grand Blanc, MI

　　Employment Type Full Time Employee

　　Job Description

　　Our mission

　　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. We are here to support you every step of the way.

　　Our brand promise

　　We deliver a collaborative experience by working directly with the surgical community to ensure you get the exact surgical tools you need at the right time and the right price.

　　Remarkable service: A seamless, personal process designed around you and your needs.

　　Trusted performance: Our product family is the result of years of experience championing surgeons and listening to their expertise.

　　Outstanding value: No matter the surgical specialty, we deliver quality products for all markets.

　　Our people promise

　　Excellence is our Specialty and what makes us successful is our people. We are committed to fostering a positive, empowering and growth-oriented environment where all team members are encouraged to share their opinions and ideas. That means you will work alongside an accomplished and highly collaborative team that inspires commitment to our goal in attaining excellence in everything they do.

　　Job Purpose Summary

　　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.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.

　　Major contributor within 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 of and maintain documents including; engineering drawings, labeling, IFUs, Work Instructions, etc.

　　Other duties as assigned

　　What you will need

　　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.

　　Proficency in information technology applications such as MS Word, Excel, and PowerPoint.

　　Proficiency in AutoCAD system a plus.

　　Root cause analysis and problem-solving skills. Lean / Six Sigma certification is a plus.

　　What we value

　　Customer First - We deliver extraordinary experiences.

　　Accountability - We do what we say.

　　Integrity - We do what is right.

　　Inspired - We love what we do.

　　One Global Team -We before me, always.

　　Join us today and Excel@Corza !

　　Corza Medical offers a competitive benefits package including medical, 401K, vacation and sick time, paternal leave and other benefits.

　　Corza Medical is an equal opportunity employer. Corza Medical evaluates 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.