Senior Process Development Engineer, Biomaterials

LifeSprout, Inc.; Baltimore (MD); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Competitive compensation

Professional development opportunities

Onsite presence

Job summary

LifeSprout, Inc. is seeking a Senior/Principal Process Development Engineer to lead manufacturing process development for biomaterials and medical devices in Baltimore.

The role emphasizes robust process design, equipment evaluation, data-driven optimization, and readiness for manufacturing transfer. You will collaborate with R&D, manufacturing, quality, regulatory, supply chain, and vendors to translate product requirements into scalable, compliant operations with hands-on leadership and strong

Qualifications

• Experience developing, scaling, and validating manufacturing processes for polymeric materials and medical devices.
• BS/MS in Chemical Engineering; advanced degree desirable for Principal level.
• Senior level: 5+ years; Principal level: 8+ years leading process development and validation.
• Experience using DOE, statistics, and structured experimental design to optimize processes.
• Experience defining process parameters, sampling plans, and validation approaches for regulated manufacturing.
• Experience evaluating and specifying manufacturing equipment, working with vendors, and supporting qualification/commissioning.
• Knowledge of GMP, ISO 13485, and documentation expectations for regulated production.

Responsibilities

• Lead process development, scale-up, optimization, and manufacturing transfer activities for biomaterial and medical device processes.
• Design and execute laboratory, pilot-scale, and production-scale studies to establish process windows, identify critical process parameters, and improve process robustness, yield, throughput, and product quality.
• Apply design of experiments, statistical analysis, and structured data review to evaluate process performance, understand sources of variation, and support data-driven process decisions.
• Develop process flow diagrams, process descriptions, engineering study protocols, technical reports, risk assessments, and process control strategies suitable for quality system and regulatory use.
• Evaluate manufacturing equipment, tooling, fixtures, automation options, utilities, and supporting technologies; define user requirements, compare vendor options, and make clear purchase recommendations based on technical fit, scalability, quality requirements, cost, lead time, and maintainability.
• Partner with equipment vendors and internal stakeholders to support equipment specification, procurement, installation, commissioning, qualification, and readiness for routine use.
• Support process validation strategy and execution, including development of validation plans, protocols, acceptance criteria, sampling plans, data analysis, deviations, final reports, and ongoing process monitoring.
• Troubleshoot manufacturing and process performance issues using root cause analysis, structured experimentation, and cross-functional technical review.
• Collaborate with quality and regulatory teams to ensure process development, scale-up, equipment qualification, and validation activities align with GMP, ISO 13485, and applicable medical device quality system expectations.
• Train and mentor manufacturing, engineering, and technical staff on process requirements, equipment operation, process controls, and documentation expectations.
• Support supplier and material changes, manufacturing deviations, nonconformances, CAPAs, change controls, and continuous improvement initiatives as needed.

Skills

Process development

Scale-up

Validation

DOE

GMP awareness

Education

BS in Chemical Engineering

MS in Chemical Engineering

Tools

Statistical software

Job description

LifeSprout, Inc. is seeking a Senior/Principal Process Development Engineer to lead manufacturing process development for biomaterials and medical devices in Baltimore.

The role emphasizes robust process design, equipment evaluation, data-driven optimization, and readiness for manufacturing transfer. You will collaborate with R&D, manufacturing, quality, regulatory, supply chain, and vendors to translate product requirements into scalable, compliant operations with hands-on leadership and strong