Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
The Engineering Associate Director will be responsible for overseeing remediation and cleaning validation activities across multiple campuses and product lines. This role will provide Subject Matter Expertise (SME) on Medical Device cleaning validations and have the ability to articulate the validations strategies and testing to internal and external regulatory agencies. This position will be responsible for leading a team of engineers that will closely align with internal and external partners to ensure minimal production impact and compliance while delivering on commitments. This role will be a leader for the engineering organization and should possess the necessary business acumen skills, mindset, and behaviors to promote accountability and a great work environment that aligns to Zimmer-Biomet's mission and guiding principles.
Principal Duties and Responsibilities
Ensure validation strategies, executions, and timing, align with corporate and regulatory expectations. Responsible for remediation and cleaning validation activities across multiple campuses and provide Subject Matter Expertise (SME) on those validations. Manage validation and remediation commitments via detailed timelines (PMO) to ensure resources and tasks are prioritized and achieved per expectations. Through coordination and partnership with internal customers (Operations, Corporate, Engineering, Quality, Maintenance, and Regulatory Affairs) as well as external partners, ensure testing and procurement activities are achieved per expectation. Ensure departmental budget expectations are properly forecasted and met. Take an active role in CAPA direction, reviews, ownership, and deliverables. Provide front room audit support as an SME on cleaning validations for both internal and outside agencies. Provide formal management, leadership and mentoring to a team of engineers, driving accountability, expertise, and morale.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Expected Areas of Competence
Thorough understanding of regulatory requirements as it relates to Medical Device cleaning validation strategies, documentation, and execution. Project Management Bio-materials fabrication experiences to GMP ISO requirements a plus. Knowledgeable in managing a team with direct reports that includes performance evaluations, setting priorities, recognitions, and leadership.
Bachelor's Degree in Engineering, Mathematics or Science and a minimum of 7 to 10years' progressive engineering experience including 3 or more in the direct management of group/team.
Up to 10%
At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.