Staff Engineer, Process Development

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The Staff Engineer – Process Development is a senior technical leader and highly experienced individual contributor responsible for leading the development of manufacturing concepts, advanced process designs and comprehensive characterization, optimization, and validation strategies for medical devices from concept through commercialization. This position contributes to strategic planning and provides technical expertise to support multiple projects or a major segment of the overall portfolio, focusing on Core Manufacturing Process Definition.

The role drives significant development initiatives to ensure robust, scalable, and compliant processes are in place to support new product introductions and technology transfers into manufacturing Value Streams.

Additionally, the Staff Engineer provides technical guidance across cross‑functional teams, influences product design for manufacturability, leads process development activities, and ensures compliance with regulatory and quality standards. The role champions innovation and drives complex projects or guides multidisciplinary teams to solve high‑impact technical challenges in a regulated environment. Depending on the department, the Staff Engineer may oversee project teams and mentor junior engineers and technical staff.

• Lead the technical execution of major manufacturing process development programs and strategic initiatives to enable New Product Introduction (NPI) in compliance with TMC Quality System requirements and regulatory standards.
• Provide domain‑specific technical leadership, guidance, and mentorship to engineers and project teams, elevating the technical capabilities of the team.
• Influence product design from a process perspective at a platform level (DFM/DFA) during early NPI stages.
• Partner with R&D and Design Engineering teams during early product development to drive the identification, evaluation, and implementation of new process technologies and equipment to improve OEE and reduce manufacturing cost.
• Solve highly ambiguous and complex technical challenges encountered during NPI and scale‑up with no clear precedent.
• Provide technical mentorship across engineering, R&D, and manufacturing teams.

• Responsible for developing and maintaining Manufacturing Process Design standards integrating advanced technologies and smart manufacturing principles (automation, process monitoring, data analytics) to advance manufacturing infrastructure.
• Act as the Subject Matter Design for Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes.
• Drive execution of proof‑of‑concept definition and determine fundamental manufacturing methods for new product introduction processes. Evaluate and drive the technical feasibility of implementing novel technologies and processes for NPI.
• Drive the technical execution of laboratory‑to‑scale processes and prototypes into scalable manufacturing processes by identifying critical process parameters (CPPs), material specifications, and equipment needs at platform level.
• Drive technical execution of process risk analysis (EFMEA, pFMEA) and execute process development strategies including commissioning (URS/FRS/Traceability Matrix), characterization and validation strategies (IQ/OQ/PQ) in accordance with regulatory and internal standards.
• Develop novel manufacturing concepts and advanced process designs for new product platforms.
• Lead the technical execution of acquisition and commissioning of new equipment and tooling required for new products, including test and measurement equipment, and lead their installation and validation.
• Integrate DFM and DFA principles across technical teams involved in NPI and manufacturing process design.
• Lead the assessment of Patent Situation Statements and intellectual property strategy related to manufacturing processes for new products.
• Drive significant improvements through advanced Lean and Six…