Sr Product Development Engineer II - Biopharma Devices

Socket.dev; Southampton Township (PA); On-site; USD 90,000 - 130,000; Full time

Job summary

Socket.dev is seeking a Senior Product Development Engineer II to lead strategic product development from concept through commercialization. You will guide design, validation, and regulatory activities, mentor engineers, and collaborate with manufacturing and suppliers to optimize product performance and cost.

Ideal candidates have strong 3D modeling, GD&T, and DFMEA skills, with experience in regulated environments and project leadership.

Qualifications

• BS in engineering or 10+ years in product development preferred.
• Master’s degree or equivalent certifications (PMP, Six Sigma, PE) preferred.

Responsibilities

• Lead design and development of new products from concept to launch.
• Translate market and customer requirements into manufacturable designs.
• Oversee prototyping, testing, validation, and regulatory compliance activities.
• Manage design plans, documentation, reviews, DFMEA, PFMEA, and risk mitigation.
• Develop specs, BOMs, technical packets, Assembly Instructions and Work Instructions.
• Collaborate with manufacturing and suppliers to optimize designs and processes.
• Mentor engineers and drive continuous improvement in design standards.

Skills

3D solid modeling

GD&T

DFM (design for manufacturability)

Lean Six Sigma Green Belt

Project leadership

Communication skills

Regulatory knowledge (ISO/FDA)

Problem solving

Education

BS in engineering or 10 years relevant work

Master’s degree or certifications (PMP, Six Sigma, PE)

Job description

Socket.dev is seeking a Senior Product Development Engineer II to lead strategic product development from concept through commercialization. You will guide design, validation, and regulatory activities, mentor engineers, and collaborate with manufacturing and suppliers to optimize product performance and cost.

Ideal candidates have strong 3D modeling, GD&T, and DFMEA skills, with experience in regulated environments and project leadership.