Manufacturing Engineer II
CooperCompaniesCooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.
Responsibilities
- Executes engineering assignments independently such as ECNs, NPEs, LCNs, etc
- Executes validations of intermediate complex equipment and manufacturing lines independently
- Supports experienced engineers on large scale projects such as product transfers or the integration of new products from R&D
- Owns specific equipment to perform Preventative Maintenance and Calibrations and is responsible for investigations of EIRs/MIRs
- Partners with the assigned Value Stream Team to ensure performance needs are met or exceeded by ensure enough capacity, minimum scrap variances, and labor efficiency when equipment are involved
- Ensures that manufacturing validations, processes, and procedures comply with FDA, OSHA, ISO, and corporate regulations, policies and procedures.
- Assists equipment technicians, as required, to troubleshoot equipment malfunctions
- Executing improvement programs such as cost, quality, or capacity.
- Work with technical operations to modify part designs to improve manufacturability
- Maintain a continuous improvement mindset and work with management to obtain buy in for technical improvement programs
- Perform other duties as directed by management.
Qualifications
- Engineering degree in mechanical, electrical, plastic injection molding, or similar.
- 2-5 years of engineering experience in manufacturing environment that is both labor and machine intensive is preferred.
- Intermediate knowledge of project management. PMP or equivalent desired.
- In-depth understanding of equipment, equipment qualification and process validation.
- Experience will plastic and silicone injection molding and extrusion
- Creative individual who is able to communicate and coordinate good ideas through to implementation. Ability to communicate well, both orally and written
- Six Sigma Green Belt & solid understanding of Lean Principles. Black belt desired.
- Proficiency with programs such as Excel, MiniTab, Microsoft Word, Power Point, etc.
- Familiarity with CAD programs such as SolidWorks and AutoCad
- Understanding of medical device regulations and their impact on medical device manufacturing
- Thorough understanding of medical device manufacturing, especially as it relates to FDA (GMP) manufacturing requirements
- Fluent in Spanish. Ability to communicate well in English, both orally and written.
- Passing of background check which may include verification of prior employment and educational records.