Product Development Engineer

Our client is a start-up biotech company that aims to improve lives through their research and products. They are looking to add a Product Development Engineer to their team.

Salary/Hourly Rate:

$110k – $140k

Position Overview:

The Product Development Engineer will work to bring products from lab concept to commercial manufacturing. This role supports prototyping, process development, and GMP readiness while working closely with R&D, Quality, Regulatory, and Operations teams.

Responsibilities of the Product Development Engineer:

• Lead product and process development activities that move technologies from laboratory testing to commercial scale.
• Build prototypes, run feasibility studies, and refine designs using data-driven engineering.
• Manage risk analyses, verification/validation testing, and controlled documentation.
• Create and execute GLP/GMP qualification protocols and support tech transfer to manufacturing.
• Develop test methods, conduct characterization studies, and apply statistical tools (DOE, analysis, modeling).
• Partner with Quality and Supply Chain on supplier qualification and GMP material readiness.
• Support regulatory documentation, investigations, and updates to SOPs and technical files.

Required Experience/Skills for the Product Development Engineer:

• 3+ years of experience in medical devices.
• Strong experience with design control.
• Direct experience moving medical device or biotech products from lab development to commercial production.
• Strong regulatory documentation experience and knowledge.
• Excellent communication, organization, and ability to manage multiple technical projects.

Preferred Experience/Skills for the Product Development Engineer:

• Demonstrated success supporting commercialization or scale-up activities.
• Hands-on work in GLP/GMP labs or manufacturing environments.

Education Requirements:

• Bachelor’s degree in Engineering or Life Sciences is required.

Benefits:

• Fully covered medical, dental, vision insurance, 401k, paid time off, and more.

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EOE/M/F/D/V/SO