Sr. Packaging Manufacturing Engineer- Sterile Pack
US, US, OH - West Carrollton
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 10%
Location: OH - West Carrollton
As a sterile Packaging/Sr. Manufacturing Engineer at NuVasive, each day will offer new challenges as you tackle a variety of responsibilities, including:
- Providing day-to-day sterile packaging/manufacturing support, responding with urgency to process and equipment issues.
- Coordinating the production of sterile packaging product launches (new and legacy products).
- Supporting and executing process validations (sterilization, packaging, cleaning etc.) for new products.
- Driving and providing support to quality processes (non-conformance, CAPA, change management, audits, etc.).
- Designing fixtures/tools for ergonomic improvement to packaging assembly processes.
- Conducting equipment and process validations, including IQ, OQ, and PQ.
- Applying formal problem-solving techniques to determine root cause, troubleshooting non-conforming products, raw materials and components and implementing corrective and preventative action (CAPA) plans.
- Leading the packaging processes to accurately and efficiently sterile pack implants and kits, from individual components to fully assembled finished goods.
- Interfacing with Quality Engineering to determine critical manufacturing process and control characteristics.
- Developing and executing manufacturing documentation (e.g. pFMEA, control plan, process flow, work instructions, and inspection plans).
- Performing research, design, and development of sterile packaging processes including production flow, assembly methods, and new production equipment.
- Executing the Engineering Change Process for process updates and improvements.
- Performing 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.
- Building 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.
- Ability to effectively influence others, develop consensus, and create support throughout the organization.
- Apply active listening skills during all interactions.
- Lean Six Sigma Practitioner
- Proven ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
- Bachelor’s degree (BS); ideally in a technical or engineering discipline.
- 5-7 years of experience in medical device sterile packaging/assembly operation
- Proficient with Microsoft office (word, excel, powerpoint)
- Proficiency with SAP and manufacturing software strongly preferred
Experience using statistical methods to drive process improvements
- Bachelor's degree in engineering or science.
- Minimum 2 years manufacturing engineering experience
- Experience developing and executing process and/or equipment validations
- Proven ability to prioritize, initiate, and drive projects to completion
- Demonstrated ability to apply engineering fundamentals and statistical analysis to manufacturing process trending, improvement, and troubleshooting
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 NuVasiveNuVasive, 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.