Sr. Sterile Packaging Manufacturing Engineer

US, US, OH - West Carrollton

Minimum Level of Education Required: Bachelors Degree

Percentage of Travel: Up to 10%

Location: OH - West Carrollton

Ref#: 18011

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Job Description

As the Sr. Sterile Pack Manufacturing Engineer at NuVasive, each day will offer new challenges as you provide day-to-day sterile packaging/manufacturing support, responding with urgency to process and equipment issues.

Essential Responsibilities: 

  • Coordinate the production of sterile packaging product launches (new and legacy products)
  • Support and execute process validations (sterilization, packaging, cleaning etc.) for new products
  • Drive and provide support to quality processes (non-conformance, CAPA, change management, audits, etc.)
  • Design fixtures/tools for ergonomic improvement to packaging assembly processes
  • Conduct equipment and process validations, including IQ, OQ, and PQ.
  • Apply formal problem-solving techniques to determine root cause, troubleshooting non-conforming products, raw materials, and components and implementing corrective and preventative action (CAPA) plans
  • Lead the packaging processes to accurately and efficiently sterile pack implants and kits, from individual components to fully assembled finished goods
  • Interface with Quality Engineering to determine critical manufacturing process and control characteristics
  • Develop manufacturing documentation (e.g. pFMEA, control plan, process flow, work instructions, and inspection plans)
  • Perform research, design, and development of sterile packaging processes including production flow, assembly methods, and new production equipment
  • Execute the Engineering Change Process for process updates and improvements
  • Perform product/process analysis and troubleshooting for cost reduction, quality improvement, and improved efficiency
  • Design, develop, test, source, and cost-justify various tools, machinery, and equipment for sterile packaging methods
  • Implement, maintain, analyze and react to various production data logs
  • Participate in NCMR Process in containment, root cause analysis, and implementation of permanent corrective actions
  • Build a strong collaborative working relationship with a broad range of associates spanning various disciplines and responsibilities (e.g. Manufacturing, Quality, Product Specialists, Leadership)
  • Effectively communicate information, both formally and informally, such as data, methods, findings, and remediation recommendations at all levels within the organization and with key contacts
  • Effectively teach, train, and mentor others across all functions regarding sterile packaging processes
  • Influence others, develop consensus, and create support throughout the organization
  • Apply active listening skills during all interactions
  • Lean Six Sigma Practitioner
  • Define problems, collect data, establish facts, and draw valid conclusions
  • Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

Basic Qualifications
  • Bachelor’s degree (BS); ideally in a technical or engineering discipline
  • 5-7 years of experience in medical device sterile packaging/assembly operation
  • Microsoft office (word, excel, powerpoint)
  • Proficiency in SAP and manufacturing software strongly preferred
  • Experience using statistical methods to drive process improvements

 

Preferred Qualifications
  • Med-device, Biotech, Pharma or related packaging experience preferred. 
NuVasive is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The “EEO is the Law” poster options are available here.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company's portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com. 
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