Engineering Project Engineer Senior
CooperCompaniesAbout the role
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:
This position provides project management leadership to ensure the successful delivery of global projects, aligning implementation strategies with CVIs long-range-strategic plans (LRSP). The Project Manager ensures adherence to regulatory requirements while meeting or exceeding company objectives.
Project Execution
- Manage projects through the entire project life-cycle, balancing competing priorities in alignment with CVI’s strategic goals.
- Provide expertise in project management, ensuring R&D activities comply with ISO/FDA design control regulations.
- Develop and maintain highly organized project task lists, offering clear status updates for multiple projects.
Stakeholder Collaboration
- Partners with global program sponsors, stakeholders, team members, and other project managers to define and achieve objectives, key milestones, and associated activities.
- Collaborate with R&D Management to conceptualize and implement strategies for current and future operational and tactical objectives.
Problem Solving and Reporting
- Lead meetings to address and resolve project challenges.
- Regularly report project progress to leadership teams and recommend adjustments as necessary.
Other
- Support additional departmental tasks as assigned, including working extended hours when required to meet business needs.
Travel Requirements:
- Minimal travel may be required
Knowledge, Skills and Abilities:
- Strong knowledge of ISO/FDA design control requirements for medical devices (21 CFR 820, ISO 13485).
- Proven expertise in project management methodologies, tools, and applications.
- Excellent organizational, leadership, and problem-solving skills.
- Effective communication and collaboration skills, with the ability to work across global teams.
- Experience with medical device development/transfer activities, process design and development, equipment automation, installation, and validation.
- Ability to thrive in a multi-site, cross-functional team environment.
Work Environment:
- Potential prolonged computer/monitor usage
- Infrequent exposure to the manufacturing environment
- Potential chemical exposure
Experience:
Minimum of 5 years experience in the medical device industry, including:
- Process engineering, chemical, or scientific disciplines.
- Process validation (e.g., SAT, FAT, IQ/OQ/PQ).
- ISO/FDA design transfer activities.
Education:
- Bachelor’s Degree with at least 5 years of relevant experience preferred
Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran
For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $84,039.00 and $115,052.00 per year 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.
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