Manufacturing Engineer II
About The Position
The Manufacturing Engineer will provide technical support for all Point of Care meter manufacturing operations under the direction of the Sr Manager and Technical Leads. This role will contribute to the development, design and validation of existing and new equipment or processes. Responsible for updating or writing the support documentation (Dwgs, BOMS, Assembly/Test Procedures, Operating Procedures or Instructions) for all POC products. Responsible for participating in development, writing and performing IQ, OQ, PQ and VQ’s for all POC products along with support equipment/processes. Assist and/or perform engineering studies to problem-solve, improve process reliability, or to improve product quality and/or cost. Be an active participant within the manufacturing team to drive departmental and company success.
Requirements
- Proficiency in Microsoft Office & Solidworks
- Experience with Business Operating Systems such as SAP
- B.S. in Mechanical, Electrical, or Industrial Engineering
- Strong communication and interpersonal skills
- Hands On approach to problem solving
- An understanding of FDA QSR’s and ISO regulations.
Responsibilities
- Update/create all forms of manufacturing documentation (AP/TP/OI/OP/BOM/DWG/Artwork) which conform to Quality System Regulations (QSR’s) and ISO Standards.
- Write and/or execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA), Process Master Validation Plans and Continuous Improvement studies/evaluations.
- Provide day to day technical floor support by investigation and resolution of issues that arise during the manufacturing process.
- Assist with transfer of new products to manufacturing.
- Collaborate with R&D and others to develop production processes, tools, and equipment.
- Train assemblers and operators regarding new processes and assemblies.
- Contribute to continuous improvement programs to reduce cost, cycle times and increase quality.
Benefits
- Flexible Medical, Dental, & Vision Coverage
- Competitive 401k company match
- Bonus Program
- Generous PTO and paid holidays
- Generous Tuition reimbursement
- Hybrid and flexible work arrangements
- Professional development, engagement and events
- Company marketplace for lunch and snacks
- Company subsidized cafeteria
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
