ABK Biomedical Inc. · 4 hours ago
Process Development Engineer
Columbia, MO
Full-time
Onsite
Senior Level
6+ years expABK Biomedical Inc. is dedicated to researching, developing, and commercializing innovative medical device therapies aimed at improving treatment outcomes for patients. The Process Development Engineer will be responsible for executing process development and improvement activities in accordance with Good Manufacturing Practices (GMP) in the manufacturing of medical devices.
BiotechnologyMedical DeviceHealthcareHealth CareMedical
Hiring Manager
Gary Donofrio
Responsibilities
Provide technical expertise in the development and improvement of manufacturing processes and equipment to support the production of existing and new medical device products
Undertake designated project elements in alignment with business objectives
Support the development of new automation processes from initial concept through transfer to manufacturing, ensuring compliance with current GMP standards
Develop and maintain manufacturing documentation, including standard operating procedures, work instructions, batch records, and equipment files
Collaborate with contract manufacturers and vendors on engineering activities and execute process development studies
Partner with internal product development, quality assurance, and regulatory teams to ensure compliance and alignment
Apply ISO 13485 (Quality Systems – Medical Devices – System Requirements for Regulatory Purposes) and FDA 21 CFR 820 (Quality System Regulation) practices
Assist and/or lead process risk management activities in accordance with ISO 14971
Apply best practices in process development for medical devices subject to 510(k) and/or PMA regulatory pathways in the U.S
Provide hands-on process support during development and commercial production activities
Generate and maintain design control documentation in compliance with ABK Document Control and Change Order procedures
Ensure continual quality system compliance by adhering to established and evolving requirements
Deliver projects within agreed timelines and milestones
Prepare materials for Process Design Review Meetings
Train on U.S. NRC (United States Nuclear Regulatory Commission) regulatory guides
Qualification
Required
Bachelor's degree in Mechanical or Biomedical Engineering
Minimum of 6 years of medical device product or process development experience
Strong communication skills with the ability to present and interact effectively at the senior management level
Creative thinker with demonstrated ability to generate ideas and deliver solutions; results and action oriented
Preferred
Background in Electrical Engineering or IT
Experience with automated manufacturing processes
Participation in at least one medical device development project
Company
ABK Biomedical Inc.
Founded in 2012, we are focused on researching, developing, and commercializing breakthrough medical device therapies to improve treatment outcomes and the lives of patients with benign and malignant hypervascular tumors.
11-50 employees
Funding
Current Stage
Late StageTotal Funding
$102.37MKey Investors
JP MorganSante VenturesF-Prime,Varian
2025-10-14Series D· $35M
2022-12-06Series C· $30M
2019-04-08Series B· $30M
Leadership Team
Michael Mangano
President and CEO
Gary Donofrio
Chief Commercial Officer
Recent News
2025-10-16
2025-10-15
Company data provided by crunchbase