Associate Director
Job Description
We are currently hiring a Associate Director to join our Process Engineering team in Fort Worth, TX. This person will be responsible for managing all aspects of the Fort Worth IOL Pilot Line operations and ensuring compliance with internal procedures, industry regulations, and regulatory guidelines.
Job Title: Associate Director
Location: Fort Worth, TX
Key Responsibilities:
- Supervises Pilot Line management and developing production staff to meet the needs of the IOL Development program.
- Responsible for representing the company during all audits (TUV,FDA, CORP.), visits, and technical calls and client visits
- Responsible for leading and executing IOL process validations for intraocular lenses.
- Develop departmental key performance indicators and analyze for opportunities to optimize department performance. Ensures adherence to all relevant GMP and cGMP requirements
- Accountabilities include preparing regulatory submissions (510k and PMA) and ensuring compliance to all applicable global standards (FDA, ISO, ANSI, AAMI, etc.).
- Exhibit an exceptional degree of creativity and resourcefulness.
- Applies and/or develops highly advanced technologies, scientific principles, theories and concepts.
- Supports engineering or scientific decision making by providing advice and recommendations to global project teams.
- Supply technical advice and counsel to other professionals and represent the organization in outside discussions and technical forums, such as AAMI, ANSI, ISO.
- Assure continuity of products and processes assessment feasibility, research, design, development, compliance to customer and non-customer requirements, transfer to production. Focus on implementing and executing in own area of expertise provides thought leadership in own area.
- Plans, conducts, directs, and coordinates the production of prototypes, test articles and clinical supplies for the Fort Worth R&D IOL Pilot Lines. Must have a proven track-record for leading multiple complex projects for medical manufacturing.
- Possesses an advanced knowledge of process validation, test method validations, clean room validations.
- Create and innovate at the strategic level, while providing experienced knowledge of the production of IOLs for all phases of development (feasibility through validation) to the rest of the enterprise.
- Develops short and long-term people and organizational strategy in alignment with company goals and direction.
- Leads with impact & influence and builds effective partnerships with cross-functional teams and drive the business toward achieving company objectives.
- Advises and counsels top corporate management regarding application of highly advanced technologies to achieve long-term organization goals for new product introduction and continuous improvement of processes and products.
- Able to develop and produce IOLs that meet challenging product requirements and comply with strict compliance regulations.
- The ability to enhance departmental capabilities through the implementation of new equipment and technologies.
Key Requirements/Minimum Requirements
- Bachelor's Degree or Equivalent years of directly related experience (or high school +15 yrs; Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
- The ability to fluently read, write, understand, and communicate in English
- 7 Years of Relevant Experience
- 5 Years of Demonstrated Leadership
- Work hours: 40 hours
- Travel Requirements: 10% domestic
- Relocation assistance: yes
- Sponsorship available: no
Preferred Qualifications/skills Experience:
- Manufacuring and sterilization experience is a plus
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [email protected] and let us know the nature of your request and your contact information.
Date Posted
04/02/2023
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