Senior Medical Packaging Engineer: End-to-End Sterile

BD

Kentucky

On-site

USD 95 - 153,400

Full time

14 days+

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Job summary

BD is seeking a Packaging Engineer to own packaging goals for aseptic and non-aseptic medical devices, leading design control for complex projects and aligning with global standards. You will translate customer needs into engineering requirements and drive packaging strategy on cross‑functional teams.

The role requires 5–8 years in packaging engineering within medical devices or pharmaceuticals, with expertise in DFSS, DOE, FEA, and verification by analysis.

Qualifications

  • Bachelor’s degree in Packaging, Mechanical, Biomedical Engineering or related field; advanced degree preferred.
  • 5-8 years of packaging engineering experience in medical device or drug development.
  • Experience developing sterile packaging systems and meeting ISO 11607-1/2, ISO 13485, ISO 16975, ICH, and related standards.
  • Expertise in DFSS, statistical methods, and Design of Experiments methodologies.
  • Ability to define and document packaging requirements for sterile packaging solutions.
  • Proficient designing packaging system types for medical devices and pharmaceutical products.
  • Experience with CAPE or TOPS and SolidWorks for packaging design.
  • Verification and validation of sterile packaging systems; PFMEA/DFMEA.
  • Experience with FEA and design verification by analysis; strong engineering fundamentals.

Responsibilities

  • Own BDG's packaging goals and align with domestic and international guidelines.
  • Lead design control process for medium and high complexity projects.
  • Translate customer needs into engineering requirements and packaging specifications.
  • Represent R&D Packaging on cross‑functional teams to drive packaging strategy.
  • Mentor junior staff and share technical knowledge while driving timelines.

Skills

DFSS
Statistical analysis
Design of Experiments
Communication

Education

Bachelor’s degree in Packaging, Mechanical, Biomedical Engineering or related field
Advanced degree preferred

Tools

CAP E
TOPS
SolidWorks

Job description

BD is seeking a Packaging Engineer to own packaging goals for aseptic and non-aseptic medical devices, leading design control for complex projects and aligning with global standards. You will translate customer needs into engineering requirements and drive packaging strategy on cross‑functional teams.

The role requires 5–8 years in packaging engineering within medical devices or pharmaceuticals, with expertise in DFSS, DOE, FEA, and verification by analysis.

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