Senior Manufacturing Engineer

at  CooperSurgical

The Senior Manufacturing Engineer for Media is an experienced engineering position with 2 or more reports. This position will provide engineering and technical services to internal customers to achieve the overall manufacturing goal of consistently producing quality, low-cost products which meet or exceed customer expectations by addressing major production problems, ensuring optimum manufacturing methods and techniques and implementing cost improvement programs.
The Senior Manufacturing Engineer will support large, complex engineering assignments, validations of equipment, and perform investigations for quality issues. The Senior Manufacturing Engineer will manage large scale projects and will often manage a cross-functional project team.
CooperSurgical is a globally provider of more than 600 products, each with a focus on improving the health of women, babies and families additionally is a Premier Provider of Medical Devices, Fertility and Genomics Solutions.

QUALIFICATIONS:

• Engineering degree in chemistry, biomedical, microbiology or similar.
• 7-10 years of technical experience in manufacturing environment of medical devices and/or pharmaceutical industry that is both labor and process oriented.
• In-depth knowledge of project management, PMP preferred.
• In-depth understanding of laboratory equipment, equipment qualification and process validation.
• Experience with laboratory and chemistry equipment such as weighing scales, mixing processes and steam sterilizers is an advantage.
• Excellent problem solving skills and ability to work effectively in a team environment.
• Creative individual who is able to communicate and coordinate good ideas through to implementation.
• Strong communication skills with the ability to interface with stakeholders at all levels of the organization.
• Expertise in lean manufacturing principles and Six Sigma methodologies. Six Sigma Green Belt (Black Belt preferred).
• 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 regulations, (GMP) manufacturing requirements and ISO standards.
• 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.
  CooperSurgical does not discriminate against any employee or applicant for employment because of race, color, religion, sex, sexual orientation, gender identity or expression, age, national origin, disability, genetic characteristic, or other characteristics protected by law. Company policy also prohibits harassment of employees or applicants based on these characteristics.

• Executes complex engineering assignments independently such as ECNs, NPEs, LCNs, etc.
• Executes product transfers and acquisitions, managing the project throughout the PTR/PAR process.
• Works cooperatively with Technical Operations, Quality, Production, Regulatory, Equipment Engineering, Supply Chain, and Marketing on complex projects to ensure project success.
• Executes validations of complex processes of manufacturing lines related to ART Media.
• Prepares complex reports and communicates results to the technical community.
• Analyzes, summarizes and provides conclusions from complex test results.
• Ensures that ART Media manufacturing validations, processes, and procedures comply with FDA, OSHA, ISO, and corporate regulations, policies and procedures. Participates in audits and inspections as necessary.
• Leads efforts to optimize manufacturing processes of ART Media, focusing on quality enhancement, efficiency and cost effectiveness.
• Investigates and resolves technical issues through structured problem solving methodologies to prevent recurrence and improve overall process reliability.
• Partners with the assigned Value Stream Team and drives initiatives for continuous improvement, lean manufacturing and Six Sigma methodologies to reduce waste, optimize productivity and enhance product quality.
• Maintains a continuous improvement mindset and works with management to obtain buy in for technical improvement programs.
• Works with technical operations to assess material changes to improve manufacturability.
• Mentors engineers with guidance on technical challenges and professional development.
• Assures that appropriate resources (personnel, tools, etc.) are maintained, in order to assure Quality System compliance and adherence to the Quality Policy.
• Perform other duties as directed by management.