Technical Project Manager — Medical Device Validation & Transfer

Location: Baltimore, MD

• Develop and maintain an integrated, task-level validation project plan covering deliverables, owners, resources, prerequisites, dependencies, milestones, approval points, and completion evidence.
• Lead several ongoing validation efforts across medical device manufacturing, assembly, equipment qualification, and supporting processes.
• Coordinate development and maintenance of Validation Master Plans, ensuring alignment between validation strategy, process risks, execution priorities, and project schedules.
• Partner with the Lead Process Validation Specialist to assess process characterization, technical gaps, and readiness before formal IQ, OQ, and PQ execution.
• Apply medical device and assembly process validation expertise to challenge proposed strategies, acceptance criteria, sampling plans, and statistical rationales.
• Coordinate Process Development, Engineering, Manufacturing, Quality Assurance, Quality Control, Regulatory, suppliers, and external laboratories.
• Manage critical-path activities, resource constraints, risks, assumptions, issues, dependencies, and recovery plans.
• Lead planning, Gantt Charts, readiness, progress, and issue-resolution meetings; communicate actionable status and decisions to project leadership.

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• Approximately 15+ years of relevant validation, manufacturing engineering, process engineering, or quality engineering experience, including substantial experience in medical devices.
• Demonstrated expertise in medical device manufacturing and assembly and test process validation.
• Strong expertise in Validation Master Plans, risk assessments, and IQ/OQ/PQ strategy and execution.
• Strong applied statistical analysis skills, including the ability to evaluate sampling rationales, process capability, experimental designs, and validation conclusions. JMP software knowledge is a plus.
• Experience supporting design transfer, technology transfer, manufacturing scale-up, or commercialization.
• Experience working within an ISO 13485 quality system, Class 8 Cleanroom environments and an FDA-regulated medical device environment..
• Ability to work onsite in Baltimore, Maryland.

• Electrospinning process experience is a significant advantage.
• Experience with biomaterials, polymers, fiber manufacturing, or implantable medical devices.
• Experience coordinating packaging, sterilization, test method, cleaning, or facility and utility validation.
• Experience managing external laboratories, contract manufacturers, equipment suppliers, and validation service providers.
• PMP, ASQ CQE, CRE, Lean Six Sigma, or comparable certification.
• Current residence in the Baltimore area or willingness to relocate.