Senior​/Principal Process Development Engineer

Senior / Principal Process Development Engineer

About Life Sprout Life Sprout was founded in September 2015 as a Johns Hopkins University spin‑out. We are a medical device company creating revolutionary products for aesthetic and reconstructive medicine. Our synthetic biomaterial platform mimics the look and behavior of native tissue and is being developed into a suite of products to restore form and function for millions of patients with soft tissue loss from aging, cancer, and metabolic disease.

The company is led by a management team experienced across business, clinical, and scientific disciplines.

This hands‑on role is responsible for developing, scaling, optimizing, and validating manufacturing processes for Life Sprout’s biomaterial platform and finished medical devices. The position will own process development from laboratory and pilot‑scale studies through manufacturing transfer, with emphasis on robust process design, equipment evaluation and selection, data‑driven process optimization, and validation readiness. The role will work closely with R&D, manufacturing, quality, regulatory, supply chain, and external equipment vendors to translate product and process requirements into scalable, controlled, and compliant manufacturing operations.

• Lead process development, scale‑up, optimization, and manufacturing transfer activities for biomaterial and medical device manufacturing 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.

• Hands‑on experience developing, scaling, optimizing, and validating manufacturing processes for polymeric materials, biomaterials, medical devices, pharmaceuticals, or other regulated products.
• BS or MS in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, Polymer Science, or related engineering discipline; advanced degree desirable for Principal level.
• Senior level: 5+ years of relevant hands‑on process development, scale‑up, manufacturing engineering, or process validation experience. Principal level: 8+ years of relevant experience with demonstrated leadership of complex process development, scale‑up, equipment selection, and validation programs.
• Demonstrated experience using…