Senior Engineering Project Manager

Röchling Medical • Lancaster, CA

13d • Hybrid

About The Position

At Röchling Medical, we're united by a shared purpose: improving lives through innovation in health. As a trusted partner to leading pharmaceutical, biotech, and medical device companies around the world, we develop customized products and solutions that help advance patient care and save lives.

Your role
ROLE SCOPE AND COMPLEXITY
Lead strategic customer programs involving products or technologies that may be new to Roechling Medical and require integrated development and manufacturing capabilities. Lead projects through a global network of Roechling Medical sites, cross-functional groups, and five or more key stakeholders, including customer, sales, and technical representatives. Programs may influence approximately $5 million to $10 million in annual revenue and include budgets of up to $1 million.

Requirements

• Bachelor’s degree in engineering or a related technical field; Mechanical, Electromechanical, Biomedical, or Biomechanical Engineering preferred.
• Requires 10+ years of progressive project management experience leading complex medical device programs through development, design transfer, validation, manufacturing scale-up, and commercialization.
• Broad knowledge of metal-plastic and electromechanical medical device manufacturing, including molding, metal processing, joining, automated assembly, electrical and functional testing, cleanroom controls, sterilization, packaging, and distribution qualification.
• Familiarity with design for manufacturability and assembly, tolerance analysis, process capability, and production scale-up.
• Strong knowledge of medical device design controls, risk management, configuration and change control, statistical methods, and product lifecycle management.
• Working knowledge of FDA requirements, ISO 13485, ISO 14971 and customer standards.
• Experience coordinating verification and validation, usability, biocompatibility, sterilization, packaging, software validation, equipment qualification, test methods, and cleaning validation.

Nice To Haves

• Strong preference for experience with metal-plastic assemblies, finished electromechanical devices, global cross-functional teams, and direct customer engagement in a CDMO environment.
• Basic SolidWorks proficiency preferred.

Responsibilities

• Create and communicate integrated project plans covering scope, deliverables, resources, schedule, budget, risks, decisions, and status. Apply critical path analysis, visual project management, and emerging AI tools to strengthen project planning and execution. Adjust plans as requirements change, control approved scope changes, address performance gaps, and manage expenses, labor hours, and customer invoicing.
• Lead gated governance from opportunity assessment through commercialization, including feasibility, technical risk, development, design, manufacturing readiness, validation, launch, and post-launch reviews. Define gate criteria, required evidence, accountable owners, escalation paths, and customer approvals.
• Serve as the primary customer interface across technical, quality, regulatory, commercial, and supply-chain workstreams. Align customer and Roechling Medical responsibilities for intended use, design inputs, risk management, verification and validation, regulatory submissions, design changes, complaints, and post-launch commitments. Resolve issues, lead escalations, document decisions, and ensure timely follow-up.
• Lead product realization from customer requirements through design transfer and manufacturing release, coordinating Engineering, Quality, Operations, Supply Chain, Procurement, and Commercial input. Manage design and process risks through FMEAs, usability inputs, measurement analysis, capability studies, control plans, inspection strategies, statistical process control, applicable production approvals, and readiness reviews. Confirm tooling, automation, test systems, controlled processes, work instructions, training, device history documentation, and production controls are launch-ready.
• Partner with Sales, Engineering, Operations, Quality, Supply Chain, and Finance to develop technically and commercially sound proposals. Before authorization, confirm scope, assumptions, exclusions, responsibilities, deliverables, development and validation costs, capital and capacity needs, tooling ownership, unit-cost targets, lead times, intellectual-property boundaries, change-order mechanisms, and launch criteria.
• Lead supplier and outsourced-process readiness for critical components, tooling, automation, test equipment, special processes, packaging, and sterilization. Coordinate selection, technical agreements, qualifications, capacity and continuity assessments, incoming controls, change notifications, and escalation to keep commitments aligned with project timing and customer requirements.
• Lead launch readiness and post-launch stabilization by confirming validated processes, released documentation, approved suppliers, production capacity, quality controls, traceability, and customer acceptance. Monitor yield, throughput, cost, delivery, complaints, nonconformances, and corrective actions until targets are sustained and ownership transfers to Operations.
• Maintain accurate, current, and traceable project records for approved scope, schedules, budgets, risks, decisions, customer approvals, change orders, validation commitments, readiness evidence, and closure in accordance with the quality management system and customer agreements.
• Perform other duties as assigned.

Benefits

• Health Management: Your health and well-being are important to us. Take advantage of our diverse health offerings, such as the health clinic.
• Training and Development: Our focus is on the continuous growth of our team members. We want to ensure that everyone can reach their full potential, which is why we offer tailored training programs for various roles. This helps you achieve peak performance and boosts your professional success!
• Food: Our sites offer vending machines with a variety of snacks and food options for you to enjoy - perfect for added flexibility during shift work, ensuring convenient access to refreshments at any time.
• Flexibility: Flexibility leads to efficiency – that’s what we believe. That's why mobile work is possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior