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.ent.
In-depth understanding of equipment qualification and process validation when it comes to medical devices industry.
The ability to read manuals and schematics is required (PLC, pneumatics, electronics and mechanics).
Creative individual who is able to communicate and coordinate good ideas through implementation. Ability to communicate well, both orally and written
Six Sigma Green Belt & solid understanding of Lean Principles.
Advanced skills with programs such as Excel, MiniTab, Microsoft Word, Power Point and MRP systems as well etc. Solidworks and AutoCad familiarity is a plus.
Thorough understanding of medical device manufacturing, especially as it relates to FDA (GMP) manufacturing requirements
Fluent in Spanish. Advanced English proficiency (written and verbal).
Passing of background check which may include verification of prior employment and educational records
Ability to balance people leadership responsibilities with technical and business objectives.
Demonstrated ability to lead, coach, and develop technical professionals.
Strong interpersonal and relationship-building skills.
Ability to create a culture of trust, accountability, employee engagement, and continuous improvement.
High emotional intelligence with the ability to understand team dynamics and effectively support individual employees’ needs.
Excellent conflict resolution and communication skills.
Experience
5+ years of engineering experience in a medical devices manufacturing environment.
2+ years of supervisory, team lead, or people management experience.
Experience leading engineering projects and working with cross-functional teams.
Experience supporting investigations, root cause analysis, and implementation of corrective actions
Demonstrated ability to coach, mentor, and develop employees.
Education
Bachelor’s Degree in Engineering: Mechanical, Electrical, Electromechanical, Chemical, or related fields.
Lean Six Sigma certification
Project Management certification preferred
Master’s Degree preferred
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 talent.acquisition@coopersurgical.com