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- MEDFORD, NY
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Apex Systems • MEDFORD, NY
Posted 10 days ago
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For immediate consideration, please email Chris Crimmins at [Click Here to Email Your Resumé] and attach your most updated resume.
Excellent DIRECT HIRE opportunity to join a diagnostics solutions company in the Medford, NY area as a Manufacturing Engineer.
Two Positions/Two Different Shifts - 1st shift (8-5) or 2nd shift (3-12)
Title: Manufacturing Engineer
- Support the IVD device manufacturing operation
- Support the transfer of new products into manufacturing
- Provide daily floor support of an assigned business unit manufacturing line for real time resolution of issues and observations for CPI new initiatives
- Preparation of Engineering Change Order (ECO) packages including BOM updates, standard operational procedure (SOP) updates, drawing updates, raw material specifications and batch records.
- Analysis and reporting to management of Statistical Process Control (SPC) data from production operations in real time
- Perform various engineering studies including DOEs, time studies and technical feasibility of new manufacturing process changes.
- Completion of CAPA projects as assigned by supervisor
- Support IQ/OQ/PQ of new equipment and process transfers to manufacturing including writing of protocols and final reports
- Manage collateral duties as assigned by Eng. Manager (examples: equipment calibrations or departmental training matrix updates)
- Work with manufacturing operations to develop standards for existing and new products
- Manage outside vendor engineering projects as assigned by Engineering Manager such as new or upgraded existing mold tooling qualifications and contract manufacturing activities
- Design of new tools and fixtures to improve manufacturing efficiency
- B.S. in Mechanical Engineering
- 5+ years’ experience working in an FDA regulated manufacturing environment; Understanding of FDA and ISO regulations.
- Experience in completing assigned CAPAs, and Root Cause Investigations.
- Experience conducting equipment and process qualifications (IQ/OQ/PQ).
- Demonstrated problem-solving and troubleshooting skills, including root cause analysis
- Green belt certification or experience utilizing Quality Engineering and Process Excellence tools is preferred. Advanced Quality tools include Risk Assessment, Failure Modes Effect Analysis (FMEA), SPC, Root Cause Analysis, Design of Experiments (DOE), Mistake Proofing / Poke Yoke, etc.
- Automation and Validation experience a plus
- Demonstrated ability to effectively work cross functionally with other departments including R&D, Manufacturing, and QA/QC.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178