Process Engineer

Process Engineer – R&D

Location: 1000 US-202, Raritan, NJ 08869

Role Overview

The Staff Process Engineer in Biosurgery R&D will collaborate with a multidisciplinary team of scientists and engineers to develop innovative and differentiated hemostats, sealants, and adhesion-prevention solutions that address critical unmet surgical needs. This role combines hands-on laboratory process development with strategic collaboration across research, manufacturing, and quality functions to ensure successful product scale-up and launch.

Key Responsibilities

• Lead R&D process development activities for surgical products, including hemostats, sealants, and adhesion-prevention solutions, aligned with strategic priorities.
• Author and maintain work instructions, build protocols, and validation documentation (IQ/OQ/PQ, FAT) for GLP and cleanroom processes.
• Collaborate with equipment vendors to identify, implement, and qualify advanced technologies; plan and support trials at vendor sites.
• Manage capital appropriation requests and POs related to equipment and vendor services, ensuring timely closure.
• Specify, procure, and qualify new equipment in compliance with GLP and ISO 8 cleanroom standards.
• Design experiments and execute activities such as equipment selection, process validation, process capability studies, and FMEA analysis.
• Partner with cross-functional teams (Clinical, Regulatory, Quality, Supply Chain, Operations) to drive projects from concept to commercialization.
• Incorporate manufacturability considerations to enable smooth scale-up from R&D concepts to full production processes.
• Perform hands-on laboratory development, analyze and interpret experimental data, document findings, and manage multiple concurrent projects.

Qualifications & Experience

• Bachelor’s degree in Chemical Engineering, Materials Science, or related field required; M.S. or Ph.D. preferred.
• 10+ years of process development experience in medical device or pharmaceutical environments.
• Experience with powder and sheet handling, drying, and auger-based powder dosing.
• Proven track record in supporting successful product launches.
• Strong knowledge of IQ/OQ/PQ documentation and execution in cleanroom settings.
• Expertise in DOE design, execution, and statistical data analysis.
• Familiarity with GLP laboratory and cleanroom practices, including equipment and room cleaning documentation.
• Experience with capital purchase processes and vendor interactions.
• Knowledge of scale-up and technology transfer to commercial manufacturing preferred.
• Ability to independently design experiments, analyze results, and implement process improvements.

Additional Skills & Attributes

• Excellent verbal and written communication skills.
• Highly organized, detail-oriented, and self-motivated.
• Strong analytical, problem-solving, and interpersonal skills.
• Passionate about innovation and continuous improvement.
• Ability to collaborate across functional teams and influence outcomes.
• Willingness to travel domestically and internationally up to 15%.