Demo

Senior Engineer, Packaging Engineering - Individual Contributor

Dexian - DISYS
Fremont, CA Full Time
POSTED ON 2/15/2025
AVAILABLE BEFORE 5/1/2025

Responsibilities :

  • Support EU MDR execution and implementation on SNV products.
  • Design and develop best in class packaging and labeling solutions from early concept through commercialization for sterile and non-sterile medical devices.
  • Drive continuous improvement and assessment of current procedures and Voice of the Customer input and identify best practices.
  • Develop packaging and labeling components that improve the customer experience, working with a drafter to develop 3D models and Artwork.
  • Demonstrate development life cycle knowledge through delivery of high-quality deliverables.
  • Work cooperatively with quality, manufacturing, regulatory, clinical, marketing, R&D device designers, supply chain, vendors, and kitting centers - across geographies to ensure project success.
  • Build Quality into all aspects of product development and support by maintaining compliance to all quality requirements and leading improvements and development of solutions that make it easier for the organization to maintain compliance in complex areas (such as ever-evolving regulatory requirements worldwide).
  • Support audits, non-conformances and CAPAs as needed.
  • Lead small- scale Packaging / Labeling projects or co-manage large-scale programs to drive changes across the portfolio.
  • Mentor or supervise technical staff as needed.
  • Role-model a high level of service and responsibility in managing a high and varied workload from internal clients and working to tight timelines.

Basic Qualifications :

  • B.S. degree in Packaging, Industrial, Mechanical engineering, or applicable technical field.
  • 3 years of experience in a highly regulated industry.
  • Preferred Qualifications :

  • Demonstrated experience in medical device, biotech, or pharmaceutical packaging design development desired.
  • Demonstrated experience in resolving design and process related packaging issues on commercial products.
  • Functional knowledge of Design Controls and Industry standards in Packaging Design and Testing (11607, ASTM, ISTA)
  • Knowledge in database driven Labeling Systems, label and IFU development.
  • Experienced in Statistical Analysis, interpretation, and communication of results.
  • Excellent interpersonal and communication skills
  • Strong technical capabilities and project management capabilities to develop aspects of assigned projects on time and within budget.
  • Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.

    Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit

    https : / / dexian.com /

    to learn more.

    Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

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