Senior Manager, Package Engineering (Medical Devices)

Location: Audubon, Pennsylvania, United States

Company

Develops medical technologies and musculoskeletal implant solutions designed to improve surgical outcomes and patient recovery.

What you will do

• Lead sterile barrier packaging design and development for musculoskeletal implants.
• Guide process validation for new packaging configurations and packaging production lines.
• Establish and follow the packaging design and development framework within the product development process.
• Manage supplier- and site-initiated changes to packaging materials, devices, and components.
• Perform transportation studies to verify protection of medical devices throughout the supply chain.
• Coordinate root cause investigations, improve manufacturing reliability and compliance, and mentor mid-level packaging engineers.

Requirements

• Bachelor’s degree in engineering, science, biomedical engineering, or a related technical field.
• 7–10 years of experience in medical device or equivalent regulated packaging engineering design and development.
• Working knowledge of ISO 11607 Parts 1 and 2, ISO 13485 design controls, and ASTM medical device packaging verification and validation tests.
• At least 2 years of experience working in a packaging engineering test laboratory.
• Strong English communication skills for collaboration with operators, global and local colleagues, stakeholders, manufacturing sites, and suppliers.
• Strong analytical, interpersonal, collaboration, and independent problem-solving skills.

Nice to have

• Master’s degree in science.

Culture & Benefits

• Values innovation focused on improving patient care.
• Customer-focused, responsive, and results-oriented working environment.
• Collaborative culture built around teamwork, accountability, and mutual respect.
• Equal employment opportunity and commitment to an inclusive workplace.