Sr. Director of Operations

Job Description

Job Description

Description:

Overview:

The Senior Director of Operations, reporting to the corporate COO, will oversee all areas of manufacturing operations in our Gardner, MA facilities to ensure that products are manufactured to quality, cost, and delivery targets. Responsible for Supply Chain Management, Material Planning, Inventory Management, Manufacturing Engineering and New Product Introduction into manufacturing. Drives implementation of Lean manufacturing and continuous improvement in manufacturing. Accountable for Operations P&L and KPIs and metrics.

Principal Responsibilities:

• Oversee planning, purchasing, inventory management, manufacturing & order fulfillment.
• Drive development and implementation of strategic initiatives to transform and continuously improve manufacturing processes and scale up capacity and capabilities.
• Develop plans, schedules, procedures, and systems for maintaining high standards of manufacturing operations to ensure that products conform to established quality, cost, and delivery targets, for high mix, low volume as well as high volume products.
• Manage the Operations budget and P responsible and accountable for Operations KPIs and metrics.
• Provide staff to all phases of Product Development & NPI programs to meet DFM, DFT, and DTC goals.
• Responsible for the MRP elements of the ERP system including establishing and executing standardized transactional workflows from order entry to fulfillment, maintenance of standard material and labor costs, and traceability.
• Foster a collaborative and high-performance culture based on Lean and continuous improvement principles. Utilize best practices, technological advancements, and industry benchmarks to enhance quality and productivity, maximize throughput, and reduce costs.
• Provide strong leadership and mentorship to the manufacturing engineering team; manage new product introduction into manufacturing.
• Support departmental compliance with the QMS, FDA QSR, ISO 13485, and other regulatory requirements.
• Implement and maintain safety procedures to meet applicable federal and state regulations.
• Oversee the specification, costing, build-out, provisioning, commissioning, and ongoing maintenance of all operations areas including bio-controlled ISO Class 7 cleanrooms. Initiate and manage large-scale projects such as facility build-outs/upgrades and re-layouts.
• Interface with key customers during negotiations around pricing, and manufacturing/quality agreements.
• Assist company officers and senior staff members in the development and formulation of long and short range strategy, planning, policies, programs, and objectives.
• Partner with Engineering and other departments to ensure alignment of Operations activities with cross company goals; ensure individual and team goals are aligned with corporate strategic objectives.
• Perform miscellaneous duties and projects as assigned and required.

Training, Skills, Knowledge and/or Experience:

• 10+ years’ experience in manufacturing and/or manufacturing engineering management, preferably in process-oriented operations in a regulated environment. A minimum of 5 years’ experience managing a significant segment of a large manufacturer or the entire operation of a smaller manufacturer.
• Demonstrated experience in scheduling, manufacturing resource & capacity planning, sourcing, and building strong relationships with employees and vendors.
• Proven success in transforming manufacturing processes and driving Lean principles to improve quality and efficiency; rollout of Lean manufacturing methods and tools.
• Demonstrated organizational and leaderships skills; demonstrated ability to scale operations by creating and implementing new organizational structures and roles to support rapid growth.
• Experience with setting up and managing Cleanrooms, ERP system implementation & usage.
• Medical device FDA QSR and ISO 13485 experience required; defense/aerospace experience desired.
• Proficiency with Microsoft 365 apps suite, and project management tools.
• Strong leadership skills with the proven ability to inspire and motivate teams to achieve exceptional results.

Education Requirements:

Bachelor’s degree in industrial or mechanical engineering, or a related technical field; or an equivalent combination of education and experience. Master's degree in engineering or business preferred.

Supervisory Responsibility:

Directly responsible for supervising exempt and non-exempt manufacturing and engineering, office/administrative, and professional employees.

Working Conditions:

This job operates in manufacturing, laboratory and office environments.

Physical surroundings:

This role routinely uses standard office equipment such as computers, phones, photocopiers, and filing cabinets. PPE required when in controlled environment rooms.

Physical Effort:

While performing duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; talk and hear.

Travel:

15% overall travel; on-site presence at POC’s manufacturing facilities in Gardner, MA