Biopharma Product Development Lead — From Concept to Launch

Newage-Industries

Southampton Township (PA)

On-site

USD 110,000 - 140,000

Full time

9 days ago

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Job summary

Newage-Industries is seeking a Senior Product Development Engineer II to lead strategic development initiatives from concept to commercialization. You will mentor the engineering team, support cost reductions, and drive design control activities in a biopharmaceutical and fluid transfer context, ensuring GMP, ISO, and QMS alignment.

Responsibilities include leading complex programs, translating market needs into robust designs, overseeing prototyping, validation, and regulatory activities; and

Qualifications

BS in engineering or 10 years in field; Master’s or certs preferred.
8+ years experience in product development, preferably single-use systems.
Proven success leading complex design projects from concept to production.
Knowledge of 3D CAD, QA standards, and reading drawings.
Familiar with ISO, FDA, IEC regulatory standards.

Responsibilities

Lead design and development from concept to finished product.
Translate market requirements into manufacturable designs.
Oversee prototyping, testing, validation, and regulatory activities.
Prepare design plans, documentation, DFMEA/PFMEA, risk mitigation.
Develop BOMs, assemblies, work instructions.

Skills

Project leadership

Cross-functional

Design control

3D CAD

GD&T

DFM

Problem solving

Communication

Regulatory familiarity

Education

Bachelor’s degree in engineering

Master’s degree or certifications

Tools

Solid modeling software

DFMEA tooling

Product lifecycle tools

Job description

Responsibilities include leading complex programs, translating market needs into robust designs, overseeing prototyping, validation, and regulatory activities; and

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