Manufacturing Engineer I
CooperSurgical 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.
- Executes basic engineering assignments independtly such as ECNs, NPEs, LCNs, etc
- Executes validations of basic equipment, may require supervision or oversight from more experience engineers
- Supports experienced engineers perform basic tasks or validations on large scale projects such as product transfers or the integration of new products from R&D
- May be required to own specific equipment to perform Preventative Maintenance and Calibrations
- 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
- Assist experienced engineers in 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
- Engineering degree in mechanical, electrical, chemistry, biomedical, microbiology or similar.
- Technical or internship experience in manufacturing environment that is both labor and machine intensive is preferred.
- Basic knowledge project management.
- In-depth understanding of equipment, equipment qualification and process validation.
- Experience with lab and chemistry equipment such as weighing scales, mixing processes and steam sterilizers is an advantage.
- Creative individual who is able to communicate and coordinate good ideas through to implementation. Ability to communicate well, both orally and written
- Six Sigma Yellow Belt (Green Belt desired) & solid understanding of Lean Principles.
- Familiarity with programs such as Excel, SolidWorks, MiniTab, Microsoft Word, Power Point, etc.
- 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.