Job Title: Manufacturing Manager

Department: Operations

Location: Schivo Plainview NY

Reports To: Site Director

Job Type: Full-Time

Industry: Medical Device Contract Manufacturing

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Job Summary

The Manufacturing Manager is responsible for the management and oversight of Production Operations for our Plainview facilities . This role ensures that all Manufacturing activities meet customer requirements, quality standards, and regulatory requirements (e.g., FDA, ISO 13485). The ideal candidate will have strong leadership skills, deep knowledge of manufacturing processes, and a commitment to continuous improvement in a fast-paced, regulated environment.

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Key Responsibilities

Manufacturing Management

oLead all Manufacturing operations to meet and exceed KPIs in productivity, quality, cost, safety, and customer service

oBuild and maintain an effective operations management system grounded in Lean and Growth principles

oIn conjunction with site leadership, deliver on the sites Annual Operating Plan, aligning with broader business goals

Compliance & Quality

oEnsure adherence to FDA regulations, ISO 13485 standards, and Good Manufacturing Practices (GMP).

oWork closely with Quality Assurance and Regulatory teams to support audits, validations, and documentation.

oEnsure Manufacturing operations are fully compliant with safety, environmental, and quality standards (HS&E, QMS)

People Management

oDrive manufacturing team level engagement, resolve people issues proactively, and promote a positive, accountable team culture

oManage and develop a high-performing team, ensuring the right skills, behaviours, and mindset are in place

oLead, coach, and develop a team of supervisors, technicians, and operators.

oFoster a culture of accountability, teamwork, and continuous improvement.

Process Improvement

oChampion a culture of continuous improvement using Lean tools and methodologies and cross-functional collaboration with Operational Excellence, Quality, Automation and Engineering teams

oImplement Lean Manufacturing and Six Sigma tools to drive operational excellence.

New Product Introduction

oIn conjunction with engineering and quality, lead the introduction of new products, processes, and technologies into manufacturing

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Qualifications

Bachelors degree in Engineering, Manufacturing, Life Sciences, or a related field.

5+ years of experience in a medical device or regulated manufacturing environment, with at least 2 years in a leadership role.

Skilled in developing cross-functional teams and building organizational capability

Strong knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP requirements.

Familiarity with Lean manufacturing principles; hands-on Lean experience highly desirable

Proven ability to manage teams and meet Manufacturing targets in a highly regulated industry.

Proficient in SAP ERP, Microsoft systems and comfortable operating in a data-driven, KPI-focused culture

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Preferred Skills

Lean/Six Sigma certification (Green Belt or higher).

Strong problem-solving, communication, and interpersonal skills.

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Work Environment

Primarily manufacturing floor with some office work.

Use of personal protective equipment (PPE) and adherence to cleanroom protocols as required.

May require occasional shift work or extended hours based on Manufacturing needs.

SALARY PRODUCTION MANAGER-UP TO $120,000 A YEAR

Schivo

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