Job Title: Manufacturing Manager Department: Operations Location: Schivo Plainview NY Reports To: Site Director Job Type: Full-Time Industry: Medical Device Contract Manufacturing

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.

Key Responsibilities: Manufacturing Management o Lead all Manufacturing operations to meet and exceed KPIs in productivity, quality, cost, safety, and customer service o Build and maintain an effective operations management system grounded in Lean and Growth principles o In conjunction with site leadership, deliver on the sites Annual Operating Plan, aligning with broader business goals Compliance & Quality o Ensure adherence to FDA regulations, ISO 13485 standards, and Good Manufacturing Practices (GMP). o Work closely with Quality Assurance and Regulatory teams to support audits, validations, and documentation. o Ensure Manufacturing operations are fully compliant with safety, environmental, and quality standards (HS&E, QMS) People Management o Drive manufacturing team level engagement, resolve people issues proactively, and promote a positive, accountable team culture o Manage and develop a high-performing team, ensuring the right skills, behaviours, and mindset are in place o Lead, coach, and develop a team of supervisors, technicians, and operators. o Foster a culture of accountability, teamwork, and continuous improvement. Process Improvement o Champion a culture of continuous improvement using Lean tools and methodologies and cross-functional collaboration with Operational Excellence, Quality, Automation and Engineering teams o Implement Lean Manufacturing and Six Sigma tools to drive operational excellence. New Product Introduction o In conjunction with engineering and quality, lead the introduction of new products, processes, and technologies into manufacturing

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

Preferred Skills: Lean/Six Sigma certification (Green Belt or higher). Strong problem-solving, communication, and interpersonal skills.

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 Medical

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