Engineering Associate Director
Company: Zimmer Biomet
Location: Warsaw
Posted on: May 28, 2023
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Job Description:
Job SummaryZimmer 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
ResponsibilitiesEnsure 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
CompetenceThorough understanding of regulatory requirements as it
relates to Medical Device production and process controls.6 Sigma
DMAIC principalsProject Management skillsProcess validationThorough
understanding of ISO13485 requirements a plus. Knowledgeable in
managing a team with direct reports that includes performance
evaluations, setting priorities, recognitions, and
leadership.Education/Experience RequirementsBachelor's degree in
engineering, Mathematics or Science and a minimum of 7 to 10 years'
progressive engineering experience including 3 or more in the
direct management of a group/team.Travel RequirementsUp to
10%Additional InformationAt 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. As a Zimmer Biomet team
member, you will share in our commitment to providing mobility and
renewed life to people around the world. This is why we offer you a
competitive rewards package that includes medical, dental, vision,
life and disability insurance, wellness incentives, employee
assistance programs as well as paid time off for vacation and
holidays.
EOE/M/F/Vet/DisabilityPDN-993554b9-ced3-4cee-9c29-cea41d82a3c6
Keywords: Zimmer Biomet, South Bend , Engineering Associate Director, Engineering , Warsaw, Indiana
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