CooperVision, a division of CooperCompanies (NASDAQ:COO), is one of the world’s leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com
Job Summary:
Leads engineering projects focused on new or existing equipment and processes to reduce costs, improve quality, increase capacity, and increase quality. Manages all elements of project including budget and timeline, securing necessary resources, and driving projects to completion. Leads and participates in process and product validations to assure all processes comply with company specifications to include internal quality systems and external regulations (FDA/ISO). Provides input to management to support the development and application of current/new business processes. Provide high level technical support to the business from the onset of project initiation through post implementation.
Essential Functions & Accountabilities:
Leads cross functional projects with a focus on increasing capacity, reducing costs, improving quality, and improving customer satisfaction. Inclusive of equipment builds (up to $5million), complex process changes, facility and/or EHS improvements and renovations.
Develops and maintains in depth knowledge of facility, equipment, processes, and products within West Henrietta
Creates and updates project deliverables in support of project objectives. This includes various forms of plans and records in formats to include Microsoft Project, Excel Spreadsheets, Word Documents, and presentation format.
Facilitates meetings (and produces related documents such as agendas and minutes) to review and update portfolio, program and project information.
Effectively applies PM Tools and Methods with sponsors, resource managers, and other stakeholders, and counsels them on appropriate use and application.
Works closely with other local and global project managers on related projects or programs on dependencies such as managing issues and risks, updating schedules and predecessors/successors, communication planning, and creating other plans and records.
Works collaboratively in a fast paced, agile environment where close teamwork and partnering are the order of the day. Builds positive, productive working relationships across the organization.
Addresses project challenges effectively, evaluating alternatives, proposing and implementing solutions, and taking corrective action as necessary.
Lead equipment and process assessments, appraisals, capability studies, and validation/verification programs in accordance with FDA and medical device regulatory requirements and provide significant technical contribution to projects.
Partner with site finance leadership team to appropriately forecast project spend, project closure, and asset assignment
Leads equipment design & procurement, including developing User Requirement Specifications (URS), vendor and proposal evaluation, (P)FMEA and process mapping creation, conducting Factory and Site Acceptance Testing (FAT and SAT), and coordinating installation activities with vendors
Reviews and provides recommendations on contractor bids, capabilities, and engineering feasibility of project proposals
Partner with site Quality team to qualify and validate new equipment, processes, packaging, and product launches
Leads engineering changes, writes Engineering Change Orders (ECOs), and documents changes appropriately in eQMS system
Travel Requirements:
Up to 10%
Qualifications
Knowledge, Skills and Abilities:
Strong project management skills with proven ability to lead cross-functional teams
Advanced skill in MS Office suite, including Word, Excel, Project, and Visio
Strong communication skills in both verbal and written / presentation formats, for both informal and formal purposes, and experience working with audiences from technical implementation staff to executive leaders.
Problem solving skills and abilities in both business and technical environments: the ability to clarify success criteria working with a team, collaboratively develop solutions and evaluate progress, and mobilize the group to take effective action to attain business goals
Excellent organizational skills
Ability to independently drive deliverables to closure
Technical competencies in mechanical and electrical systems, including process controls
Working knowledge of eQMS (Quality Systems) and FDA cGMP regulations
Knowledge of Good Documentation Practices (GDP)
Proficiency with AutoCAD preferred
Present a professional and positive presence and interface with multiple roles within the CooperVision organization
Work Environment:
Normal warehouse and office environment with regular exposure to dust, heat and cold
Experience:
Minimum 3-5 years of relevant working experience.
Education:
Bachelor’s Degree in Engineering field required. Industrial, Mechanical, or Packaging Engineering degree strongly preferred.
An equivalent combination of education and experience may be considered.
PMP certification, or interest in obtaining certification, is a positive
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $76,323 and $101,764 and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.
