Technical Project Manager — Medical Device Validation & Transfer
Baltimore, MD
Contracted
Manager/Supervisor
Technical Project Manager — Medical Device Validation & Transfer
Location: Baltimore, Maryland
Work Arrangement: Onsite
Engagement Type: Contract / Consulting
Function: Validation / Engineering / Design Transfer
Duration: 3 to 6 months
'Position Overview
VTI Life Sciences is seeking a Technical Project Manager with deep medical device manufacturing and assembly process validation expertise to lead and execute multiple concurrent validation efforts supporting design transfer, manufacturing scale-up, and commercialization.
Candidates must champion lean, scientifically sound, risk-based validation that delivers sufficient objective evidence while avoiding unnecessary testing and documentation.
Candidates who reside in the Baltimore, Maryland area or are willing to relocate are preferred. 75% Onsite availability is required.
Key Responsibilities
Required Qualifications
Preferred Qualifications
Location: Baltimore, Maryland
Work Arrangement: Onsite
Engagement Type: Contract / Consulting
Function: Validation / Engineering / Design Transfer
Duration: 3 to 6 months
'Position Overview
VTI Life Sciences is seeking a Technical Project Manager with deep medical device manufacturing and assembly process validation expertise to lead and execute multiple concurrent validation efforts supporting design transfer, manufacturing scale-up, and commercialization.
Candidates must champion lean, scientifically sound, risk-based validation that delivers sufficient objective evidence while avoiding unnecessary testing and documentation.
Candidates who reside in the Baltimore, Maryland area or are willing to relocate are preferred. 75% Onsite availability is required.
Key Responsibilities
- 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.
Required Qualifications
- 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.
Preferred Qualifications
- 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.
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