Principal Manufacturing Integration Engineer

About CooperSurgical

JOB DESCRIPTION

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 .

Work location: Trumbull, CT (on-site). This is a contract only role.

Scope:

The Principal Manufacturing Integration Engineer will lead in the establishment of manufacturing lines Globally that will produce new products within CooperSurgical sites and outside vendors.The manufacturing lines will meet the manufacturing goal of consistently producing quality, low-cost products, ensuring optimum manufacturing methods, techniques and implementing cost improvement programs. The Principal Manufacturing Integration Engineer ensures the quality of the manufacturing deliverables and timely delivery of products that meet customer needs, business objectives and strategic goals.The Principal Manufacturing Integration Engineer must maintain a proper balance between operations support and project management, serve as the Senior operations and manufacturing representative on Integration projects and product line transfers, and will interface with Product Engineering, Design Quality, Quality Engineering, Plant Engineering, purchasing, facilities and Regulatory. Typical production lines that are being set up are $1M plus in spend and can be anywhere globally.

Job Summary:

This position will take the lead on transferring/duplicating/ modifying production lines from location typically at an acquisition site and landing the production at CooperSurgical site or approved supplier.This will also typically be preparing a site to take on the new manufacturing through construction and facility modifications. A key objective will be leading the integration team through the whole process.

Responsibilities

• Demonstrated experience in setting up new and/or modifying existing manufacturing lines to produce Finished Good Medical products and subassemblies. This includes automated and manual assembly lines.
• Demonstrated experience in transferring products and related manufacturing lines between manufacturing locations.
• Manufacturing lead for assigned products and lines, to ensure that performance meets or exceeds budgeted performance (i.e. customer service level, scrap/material variances, expenses, labor productivity performance, build plan attainment and capacity analysis).
• Drives and ensures manufacturing processes and procedures comply with cGMP, FDA, OSHA, ISO, corporate and divisional regulations, policies, and procedures (i.e. process qualification/validation, operation procedures, accurate standards, documentation, etc.).
• Identifies and resolves repetitive and major production issues that are affecting department performance, especially when resolutions of such issues require technical solutions.
• Identifies and manages cost improvement programs by implementing efficiency improvements in manufacturing. Programs will typically improve manufacturing costs by reducing material costs, improving labor performance, reducing labor requirements, reducing scrap and improving machine utilization.
• Drives implementation and management of identified KPI’s.
• Generates protocols, reports for IQ/OQ/PQ and test method validations. This includes driving statistical analysis and sample size methods.
• Generates SOP’s, WI’s and subsequent manufacturing documentation.
• Provides technical support to Supply Chain to ensure a continuous and cost-effective supply of quality product components.
• Partners with QE to drive efficiency regarding variances, NCMR and CAPA’s. Monitors and drives documentation and process to ensure continuous improvement and reduction.
• Trouble shoots and implements quick manufacturing solutions to ensure production continuity is not disrupted.
• Mentors members on the team or production as required.
• Performs additional duties and assignments as directed by management.
  
  
  

Travel: Ability to travel domestically and internationally of up to 60% for extended periods of time. Typical travel will be 30% of the time and will include domestic and international travel.

Qualifications

Knowledge, Skills and Abilities:

• A proven track record of cost reduction and work simplification.
• Creative individual who can communicate and coordinate good ideas through to implementation.
• Thorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) manufacturing requirements.
• Clear understanding of DOE, Statistical analysis, and sample size determination.
• Basic understanding of construction and facilities for preparing a site to take on a new manufacturing line.
• Must be fully versed with programs such as Excel, AutoCad, Solidworks, MiniTab, Microsoft Word, PowerPoint, etc.
• Ability to lead Six Sigma / Lean projects
  
  
  

Work Environment:

• Manufacturing plants, suppliers and office setting and hotel rooms globally
• Running, validating and setting up manufacturing lines and equipment in various mfg types including cleanrooms and multiple countries
• Occasionally lift to 35 Kilograms
• Mechanical and electrical assembly, testing and trouble shooting
• Prolonged sitting in front of a computer.
  
  
  

Experience:

• 15 years’ experience in medical device manufacturing industry.
• Experience in leading and driving $1M operations integration projects.
• A proven track record of cost reduction and work simplification.
  
  
  

Education:

• BS in a technical field such mechanical, electrical or industrial Engineering. Masters preferred
• Training or certificate in CAD.
• Training or certificate in Six Sigma and Lean.
  
  
  

Our Benefits:

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.