Zimmer Biomet · 6 hours ago
Manufacturing Sr Engineer II
Claymont, DE
Full-time
Onsite
Senior Level
5+ years expZimmer Biomet is a global medical technology leader dedicated to enhancing patient mobility. The Manufacturing Sr. Engineer II will provide manufacturing engineering services, support daily production and testing of reagents for IVD assays, and ensure compliance with regulatory requirements while resolving manufacturing issues.
Health CareManufacturingMedical DeviceProduct Design
Responsibilities
Provide technical expertise and direction in multiple Immunoassay manufacturing areas
Lead multi-department teams to support/resolve non-conforming issues for existing products
Communicate investigation status reports, proposals for further investigation, etc. via oral and written reports; develop and implement changes to existing documentation in a timely manner
Solve immunoassay testing and manufacturing issues as they arise
Assess manufacturing processes and systems, and implement improvements aimed at performance, quality, and cost
Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements
Lead equipment qualification or process validation projects
Create protocols, execute, draw conclusions and author reports
Interpolate and analyze data using statistical analysis (including control charts)
Create and revise standard operating procedures including periodic review
Manage the documentation associated with the Change Control process
Author review and manage quality events including NCRs, Issue Evaluations, and CAPAs
Understands, promotes, and enforces all applicable safety protocols including chemical, biological hazards, labeling, containment, and waste handling
Understand product application and customer expectations
Work as a member of interdepartmental project teams
Qualification
Required
Experience with immunoassays is required
Candidates with practical experience in the development, validation and/or manufacture of diagnostic assays is required
The ability to read, interpret and analyze scientific data is required
The ability to effectively communicate through written and oral form is required, along with strong organizational and time management skills
Ability to define problems, collect data, establish facts, and draw valid conclusions
Good problem-solving skills through the use of quality and statistical tools
B.S.in Engineering with a minimum of 5-7 years of manufacturing engineering experience
Minimum 4 years of experience in a relevant production/manufacturing environment
Knowledge of FDA and ISO 13485 regulations as they relate to medical devices and/or in-vitro diagnostics devices
Preferred
ELISA and lateral flow technology is preferred
Work experience with ELISA assays is preferred
ISO 13485 or cGMP experience preferred
Ability to lead and prioritize complex projects and complete work in a timely manner
Experience using Microsoft Suite – Word, Excel, Visio, and Project
Minitab knowledge is preferred
Knowledge in Lean Principles and or Six Sigma or other problem-solving methodology is preferred
Knowledge on how to conduct investigations and root cause analysis is preferred
Benefits
Development opportunities
Robust employee resource groups (ERGs)
Flexible working environment
Location specific competitive total rewards
Wellness incentives
Culture of recognition and performance awards
Company
Zimmer Biomet
Zimmer Biomet is a medical device manufacturing company that offers orthopedic reconstructive, spinal, and trauma devices.
10001+ employees
H1B Sponsorship
Zimmer Biomet has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.75B2025-02-20Post Ipo Debt· $1.75B
2016-12-14Post Ipo Debt· $1B
2001-08-03IPO
Leadership Team
Ivan Tornos
Chairman, President and CEO
D
David DeMartino
Senior Vice President, Investor Relations
Recent News
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