Sr. Site Transfer Manufacturing Engineer - Shockwave Medical

Position Overview

The Sr. Site Transfer Manufacturing Engineer leads and executes product and process transfers between manufacturing sites (domestic and international), ensuring successful, compliant, and timely ramp of on‑market products. This role is the primary technical lead for multi‑site transfers, coordinating cross‑functional teams (R&D, QE, Regulatory, Supply Chain, Production, and External Partners) to deliver validated, robust manufacturing processes at the receiving site.

• Lead end‑to‑end site‑to‑site transfer projects, from transfer planning and risk assessment through validation, production ramp, and post‑transfer monitoring.
• Create and manage detailed Transfer Plans and timelines, including resource needs, milestones, deliverables, and go/no‑go criteria.
• Develop and maintain process pFMEAs, risk mitigation plans, and transfer‑specific mitigation actions.
• Define user and functional requirements for equipment and systems at the receiving site; lead equipment qualification and installation activities (IQ/OQ/PQ).
• Oversee process validation and qualification activities at both sending and receiving sites; ensure data integrity and compliance with protocols.
• Coordinate cross‑site documentation transfer: BOMs, work instructions, MPIs, LHRs, configuration control, and design control elements as applicable.
• Lead or participate in system integrations required for transfer (MES/ERP/PLM), including data migration, validation, and end‑user training.
• Plan and execute capability studies (Cpk), DOE, tolerance analyses, and other statistical evaluations to demonstrate process equivalency and capability at the receiving site.
• Collaborate with Supply Chain and Procurement to ensure material, component, and supplier readiness; qualify alternate suppliers when needed.
• Provide technical leadership during production ramp: troubleshooting, root‑cause analysis (DMAIC), corrective actions, and optimization to achieve targeted yields and throughput.
• Define and track relevant transfer KPIs (e.g., schedule adherence, yield, Cpk, cost variance) and report status to stakeholders and leadership.
• Mentor and coach engineers and technicians on site transfer best practices and regulatory requirements.
• Support regulatory submissions, audits, and inspections related to transferred products and processes.
• Travel between sites as required to lead transfers and support on‑site validations and training.

• Bachelor’s degree in Mechanical, Biomedical, Industrial, Manufacturing Engineering, or closely related field.
• Master’s degree may substitute for 1–2 years of experience.
• 5–7 years of hands‑on manufacturing engineering experience in a regulated industry (medical device preferred; pharmaceutical, automotive, or similar industries acceptable).
• Direct experience in site‑to‑site or product/process transfers (documented role as lead or co‑lead on at least one transfer or multiple process transfer projects).
• Practical experience with process validation and equipment qualification (IQ/OQ/PQ) and executing transfer validation protocols.
• Strong understanding of Quality System Regulations and standards (QSR/FDA, ISO 13485, MDR) as they apply to transfers and design control.
• Proficiency in statistical methods and tools: capability studies (Cpk), basic DOE, and use of statistical software (Minitab or equivalent).
• Hands‑on familiarity with MES, ERP and/or PLM systems and experience supporting data migration or configuration for transfers.
• Competency with CAD tools (Solid Works or similar).
• Demonstrated project management skills: develop transfer plans, schedules, resource allocation, risk assessments, and status reporting.
• Strong problem‑solving using structured methods (DMAIC, root‑cause analysis) and experience implementing corrective/preventive actions.
• Excellent written and verbal communication skills; experience preparing technical reports, transfer documentation, and training materials.
• Ability and willingness to travel to partner sites (up to 25–35% depending on project load).
• Ability to occasionally lift up to 25 lbs.

• Six Sigma Green Belt or Black Belt, or equivalent continuous improvement…