Manufacturing Manager

• 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, a deep knowledge of manufacturing processes, and a commitment to continuous improvement in a fast-paced, regulated environment.

• Manufacturing Management:

• Lead all Manufacturing operations to meet and exceed KPIs in productivity, quality, cost, safety, and customer service
• Build and maintain an effective operations management system grounded in Lean and Growth principles
• In conjunction with site leadership, deliver on the site’s Annual Operating Plan, aligning with broader business goals

• Compliance & Quality:

• Ensure adherence to FDA regulations, ISO 13485 standards, and Good Manufacturing Practices (GMP).
• Work closely with Quality Assurance and Regulatory teams to support audits, validations, and documentation.
• Ensure Manufacturing operations are fully compliant with safety, environmental, and quality standards (HS&E, QMS)
• People Management:

• Drive manufacturing team level engagement, resolve people’s issues proactively, and promote a positive, accountable team culture
• Manage and develop a high-performing team, ensuring the right skills, behaviors, and mindset are in place
• Lead, coach, and develop a team of supervisors, technicians, and operators.
• Foster a culture of accountability, teamwork, and continuous improvement.
• Process Improvement:

• Champion a culture of continuous improvement using Lean tools and methodologies and cross-functional collaboration with Operational Excellence, Quality, Automation and Engineering teams
• Implement Lean Manufacturing and Six Sigma tools to drive operational excellence.
• New Product Introduction:

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

• Bachelor’s 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

• Job Type: Direct Hire
• Salary Rate Range: $100-125K
• Location: Plainview, New York.

Protingent