Senior Process Engineer

Responsibilities

• Lead the development and scale up of Panther's automated manufacturing process for dissolvable microarray patches (MAPs).
• Partner with external engineering firms to design, develop, and implement a high throughput manufacturing line from concept through execution.
• Serve as Panther's primary technical representative with engineering vendors and contract manufacturing organizations (CMOs), ensuring projects remain on schedule, within budget, and aligned with technical requirements.
• Translate laboratory and pilot scale manufacturing processes into robust, scalable commercial manufacturing solutions.
• Identify manufacturing bottlenecks and develop engineering solutions to improve throughput, yield, quality, and reliability.
• Support technology transfer activities to external manufacturing partners while ensuring cGMP and medical device compliance.
• Participate in clinical and commercial manufacturing campaigns and drive continuous process improvements.
• Collaborate closely with Process Development, Formulation and CMC, Device Development, Manufacturing, Quality, and Regulatory teams to successfully commercialize Panther's platform.
• Travel regularly to engineering partners, vendors, and CMO facilities, approximately 25 to 40 percent.

Qualifications

• Bachelor's degree or higher in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Process Engineering, Automation Engineering, or a related engineering discipline.
• Five or more years of experience in process engineering, manufacturing engineering, or process development within medical devices, biotechnology, pharmaceuticals, or another highly regulated industry.
• Proven experience scaling manufacturing processes from pilot to commercial production.
• Experience leading complex engineering projects involving external vendors, engineering firms, or contract manufacturers.
• Strong understanding of automated manufacturing systems, process optimization, and equipment development.
• Experience working within FDA regulated, cGMP, ISO 13485, or similar manufacturing environments.
• Strong project management, communication, and cross functional collaboration skills.
• Willingness to travel approximately 25 to 40 percent.

Preferred Qualifications

• Experience building or launching new manufacturing lines or greenfield manufacturing facilities.
• Experience leading technology transfer to CMOs or external manufacturing partners.
• Knowledge of medical device quality systems, validation, and regulatory requirements.
• Experience with automation, robotics, vision systems, or high throughput manufacturing equipment.
• Experience supporting clinical manufacturing and commercial product launches.
• Experience working in a startup or other fast paced, high growth environment.