Senior Manufacturing Engineer

• Company: CooperSurgical

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 business unit of CooperCompanies (Nasdaq: COO), we're driven by a unified purpose of helping people 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 basic engineering assignments independtly such as ECNs, NPEs, LCNs, etc
• Executes product transfers and acquisitions, managing the project throughout the PTR/PAR process
• Executes product integrations from R&D
• Execute validations of complex equipment and manufacturing lines
• 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
• Define and execute 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, chemistry, biomedical, microbiology or similar.
• 5-10 years of technical in manufacturing environment that is both labor and machine intensive
• In-depth knowledge of project management, PMP preferred
• 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 Green Belt (Black Belt preferred) & 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.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.  If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at [email protected]