Senior Manager

The Senior Manager, Advanced Process Development is a critical technical and operational leader responsible for building and leading a dedicated Advanced Process Development group focused on New Product Development projects. Reporting directly to the Director – Operations Engineering, this role will unify our new process development engineering resources under one leader and establish a focused structure for launching new products with robust, scalable, and production-ready manufacturing processes.

This leader will be 100% dedicated to new product launches and to delivering stable manufacturing processes to Operations Engineering. The role will lead design transfer activities after design freeze, partner closely with product design teams to understand critical product design requirements, and translate those requirements into manufacturable electrical, mechanical, software, and test system specifications.

The Senior Manager will bring together engineering headcount dedicated to new products, including test systems and manufacturing process development resources, into a cohesive structure that improves focus, accountability, and speed of execution. This role will partner with machine builders, suppliers, Operations Engineering, Quality, Regulatory, and Product Development to design, qualify, and launch capable manufacturing equipment and processes.

This is an opportunity to create and scale an Advanced Process Development capability that strengthens design transfer, improves manufacturing readiness, and ensures new products are launched with stable, robust, and compliant production processes.

Key Responsibilities

Leadership & Organizational Responsibilities

• Create and lead an Advanced Process Development group dedicated to New Product Development projects and new product launch readiness.
• Move engineering headcount dedicated to new products into this new structure, creating a focused organization aligned to launch execution and manufacturing readiness.
• Lead, coach, and develop process development, test systems, and manufacturing engineering talent in support of new product commercialization.
• Provide clear priorities, technical direction, and execution rhythm across cross-functional launch teams.
• Develop and grow engineering talent by setting clear expectations, providing regular coaching and feedback, and building individual development plans that strengthen technical depth, leadership capability, and launch execution skills.
• Create growth opportunities for engineers through project ownership, technical problem solving, cross-functional exposure, mentoring, and structured development assignments.
• Build a strong engineering culture focused on accountability, technical excellence, collaboration, continuous improvement, and disciplined execution.

New Product Development & Design Transfer

• Lead design transfer activities after design freeze, ensuring new products move efficiently from product design into stable, qualified manufacturing processes.
• Partner closely with Product Design and R&D teams to understand critical product design requirements and their implications for manufacturing, test, and process capability.
• Translate critical product requirements into manufacturing specifications, including electrical, mechanical, software, test method, equipment, and process requirements.
• Drive technical alignment between product design intent, process capability, equipment design, and production readiness.
• Ensure launch plans include clear process development milestones, risks, mitigations, validation requirements, and handoff criteria to Operations Engineering.

Manufacturing Equipment, Test Systems & Process Qualification

• Partner with machine builders, automation providers, suppliers, and internal engineering resources to design and implement manufacturing equipment for new products.
• Own the development of capable manufacturing and test systems that support launch quality, repeatability, throughput, and long-term process stability.
• Be accountable for qualifying manufacturing processes and test systems prior to production release and handoff to Operations Engineering.
• Drive process characterization, risk mitigation, equipment readiness, and validation planning in accordance with regulated medical device requirements.

Cross-Functional Partnership

• Partner with Product Design, Operations Engineering, Quality, Regulatory, Supply Chain, and Program Management to ensure product launch plans are technically sound and execution ready.
• Serve as the primary bridge between product development and manufacturing operations for new product process readiness.
• Proactively identify design, equipment, test, process, and supplier risks that could impact launch timing, quality, cost, or manufacturability.
• Ensure stable manufacturing processes are transferred to Operations Engineering with clear ownership, documentation, training, and performance expectations.

Qualifications

Required

• Bachelor’s degree in mechanical engineering, Electrical Engineering, Biomedical Engineering, Manufacturing Engineering, or related technical field.
• 8+ years of engineering experience in medical device, regulated manufacturing, automation, test systems, process development, or new product introduction environments.
• 3+ years of direct leadership experience, including responsibility for technical teams, project execution, and cross-functional delivery.
• Demonstrated experience supporting or leading new product development, design transfer, manufacturing process development, and production launch readiness.
• Experience translating product requirements into manufacturing, equipment, test, electrical, mechanical, and software specifications.
• Experience working with machine builders, automation suppliers, contract manufacturers, or external technical partners.
• Strong understanding of medical device quality systems, design controls, process validation, risk management, and verification/validation practices.
• Proven ability to build structure, align teams, resolve technical issues, and deliver results in a fast-paced, cross-functional environment.
• Demonstrated ability to develop engineers, build technical capability, coach performance, and create career growth opportunities within an engineering organization.

Preferred

• Background in complex electromechanical systems, active implantable devices, electronics, software-enabled systems, or high-reliability medical devices.
• Hands-on experience writing test protocols, qualification protocols, engineering reports, and process transfer documentation.
• Experience scaling an advanced manufacturing, process development, NPI, or launch engineering function.
• Strong systems thinking, structured problem-solving, communication, and stakeholder management skills.

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