We are a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.
The role is responsible for planning, tracking and managing the product/process research, development and transfer to manufacturing for new contact lens projects or to support project (s) as an individual contributor as assigned. They are responsible for leading cross functional teams in interpreting customer input information into product/process requirements and ensuring the resulting materials / process reproduces lenses to these requirements on an ongoing basis. The Technical Leader is responsible for forming and managing a team to accomplish the project objectives, within the defined scope, quality, cost, and time targets to deliver the product to market or achieve other defined objectives. The role will also include functional management of direct reports.
- Key objectives development for project lifecycle of 1 to 3 years. Applies to developing key objectives, strategic plans, laboratory capabilities, etc.
- Provide input to functional managers regarding team members' performance and contribute to the establishment of functional goals.
- Establish Project Operating and Capital Equipment budget with scope up to several million dollars over multiple years.
- Manage global projects across multiple sites as required.
- Provide leadership for functional and/or cross-functional team members.
- Define project scope and work within the product development processes to identify and develop products/processes or improve existing products that deliver increased revenue/earnings to the Corporation.
- Plan and execute the feasibility establishment of key technologies required to support identified portfolio opportunities.
- Negotiate with functional leadership to assemble a cross-functional project core team. Lead team to develop the project plan and schedule to include detailed scope, strategies, quality, people resources, cost estimates and time targets to successfully develop, validate, register and launch products in targeted markets.
- Plan and manage the project capital and expense budget, including reforecasting, strategic plans and variance analysis.
- Set objectives for the team, and provide functional management with team member assessments of performance regarding quality of work, participation and deliverable achieved.
- Track and manage the project schedule and task details against the plan, analyze actual performance against the plan and make adjustments consistent with plan objectives and milestones.
- Analyze risks against project objectives and targets and determine actions and responsibilities for mitigating risks including establishing contingency plans and/or assigning responsibility for corrective actions.
- Stay informed with internal business environment or external landscape change, evaluate impact to project objectives and elevate new risks or opportunities.
- Inform management and key stake holders in a timely manner of project status, and any critical problems which may result in unsatisfactory product performance, delays in project schedule or significant changes in project cost. Lead team to develop alternate paths that mitigate any issues.
- Plan and conduct project team meeting and project review. Ensure project documentation is complete and properly maintained and filed according to company policies.
- Coordinate with Operations and Commercial leads to ensure efficient production and product commercialization through key market introduction.
- Conduct retrospective R&D project review to document project management process improvement opportunities and suggest improvements to the business processes.
- Provide functional leadership for department members
- Communicate effectively and in a timely manner with appropriate Management regarding the status, opportunities and issues involving the department, contact lens projects and information pertinent to achieving and maintaining the company's vision and mission.
- Compliance to regulations and quality systems for new product development, clinical and non-clinical development lens manufacture and new product launches including all required documentation.
- Build high performing teams capable of interacting and meeting the requirements of product and process development, research and engineering initiatives and compliance requirements.
- Conduct employee assessments to provide them feedback throughout the year on their performance relative to established objectives and expected behaviors.
- Grow and develop employees to maximize their career potential while also delivering benefits to the corporation. Develop retention and succession plans for key positions.
- Key Relationships:
- Works with internal organizations on research, development and manufacturing programs.
- Works with external technology partners to assess and integrate emerging materials, technologies and processes.
- Works with other functional managers to develop department/project budget and allocation of resource, regulatory filing strategy, QA validations plans and design control plans
- Bachelor's Degree in Science or Engineering. Master's Degree in Science, Engineering and/or Management or equivalent experiencepreferred.
- Minimum of 8 years relevant experience in medical device product development and engineering
- Previous experience in functional management of people
- Competent understanding of statistics and problem solving skills/experience; able to lead an organization and built on the tenants of Lean/Six Sigma, DFSS, and the constant use of data driven decisions