Director Operations Engineering

Position Overview

The Engineering Director is a mission‑critical leader who will shape the future of our Manufacturing Operations. Reporting directly to the Vice President of Operations & Supply Chain, this role will champion all engineering functions and play a defining role in scaling the organization for its next stage of growth.

This leader will provide strategic, operational, and technical direction across the engineering organization guiding teams through sustaining engineering activities, building a robust continuous improvement pipeline, and partnering closely with R&D to bring next‑generation products to market. They will drive high‑visibility initiatives that strengthen product quality, accelerate innovation, and prepare the company for an expanded manufacturing footprint.

The ideal candidate is a builder of teams, systems, and capability. They bring the discipline to implement scalable processes, the foresight to elevate our engineering culture, and the leadership presence to influence decisions at the highest levels of the company. They will play a pivotal role in developing future technical talent, expanding product capabilities, and ensuring compliance within a regulated medtech environment.

This is a rare opportunity to make a transformative impact shaping the technical foundation, operational readiness, and long‑term growth of a rapidly expanding organization.

Key Responsibilities

Strategic & Leadership Responsibilities

• Develop and execute the engineering strategy in alignment with the company’s business goals and long‑term manufacturing roadmap.
• Lead, mentor, and grow a high‑performing team across product development, sustaining engineering, test engineering, and technical operations.
• Build scalable engineering systems, processes, documentation, and organizational structure suitable for a future manufacturing footprint.
• Serve as the key technical voice on the leadership team, contributing to long‑range planning, risk assessment, and organizational readiness for operational scale‑up.

Product Development & Sustaining Engineering

• Oversee all engineering activities across the product lifecycle, including concept development, design, verification/validation, risk management, and post‑market support.
• Lead teams in executing New Product Development (NPD) programs from concept to commercialization in compliance with FDA, ISO 13485, and other relevant regulatory requirements.
• Manage and prioritize sustaining engineering efforts, including product enhancements, field issue resolution, cost reductions, and design improvements.
• Collaborate closely with Quality, Regulatory, Program Management, and Clinical teams to ensure products meet safety, performance, and compliance requirements.

Manufacturing Readiness & External Partnerships

• Oversee technical relationships with contract manufacturers (CMOs), suppliers, and external development partners.
• Drive process validation, DFM/DFA efforts, and transfer-to-manufacturing readiness activities.
• Develop and maintain strong supplier-quality and technical oversight processes.

Cross-Functional Collaboration

• Partner with Operations, Supply Chain, Quality, and Regulatory teams to ensure smooth product launches and ongoing production stability.
• Lead root cause analyses (RCAs), CAPAs, and risk mitigation efforts with cross-functional stakeholders.
• Support commercial teams and customer-facing functions with technical expertise as needed.

Process, Quality & Compliance

• Own engineering documentation, technical files, and design control processes.
• Ensure engineering deliverables comply with FDA QSR, ISO 13485, IEC 60601, and other applicable standards for medical devices.

Strengthen the company’s design controls, requirements management, and change control procedures.

Qualifications

Required

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related field; Master’s preferred.
• 10+ years of engineering experience in the medical device industry.
• 5+ years in technical leadership roles, managing cross-functional engineering teams.
• Proven success leading Sustaining Engineering and/or NPD programs under regulated design controls.
• Experience working with contract manufacturers and leading design transfer activities.
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, risk management (ISO 14971), and V&V methodologies.
• Demonstrated ability to build processes, mentor teams, and drive cross-functional alignment.

Preferred

• Experience in scaling manufacturing capabilities, including equipment procurement, process development, and validation.
• Background in complex electromechanical systems, wearable devices, diagnostics, or therapeutic devices.
• Strong systems engineering and root‑cause problem‑solving skills.
• Experience in a growth-stage or transformation-stage environment.

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