Operations Manager
27 days ago
Plainview
Job DescriptionJob Description Schivo Medical located in Plainview New York, manufactures a diverse range of essential medical technology solutions. Working with us, you will be manufacturing or supporting the manufacture of a vast array of different products including robotic surgery instruments, neurosurgical tools, and cardiovascular closure devices that treat chronic disease in new ways so people can live better and longer. As an employee of Schivo Medical, you will tackle a wide array of problems, including some of the world’s greatest medical challenges. You will be part of a company committed to helping you build a fulfilling and rewarding career. 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, a deep knowledge of manufacturing processes, and a commitment to continuous improvement in a fast-paced environment. Key Responsibilities: • 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., • Drive manufacturing team level engagement, resolve people issues proactively, and promote a positive, accountable team culture., • Manage and develop a high-performing team, ensuring the right skills, behaviours, and mindset are in place., • Lead, coach, and develop a team of supervisors, technicians, and operators. New Product Introduction In conjunction with engineering and quality, the introduction of new products, processes, and technologies into manufacturing. Qualifications: • 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. Preferred Skills: • Lean/Six Sigma certification (Green Belt or higher)., • Strong problem-solving, communication, and interpersonal skills, • Experience working in a CNC Production facility a plus Work Environment: • Primarily manufacturing floors with some office work., • Use of personal protective equipment (PPE) and adherence to cleanroom protocols as required., • 401(k), • 401(k)match, • Dental insurance, • Health insurance, • Vision insurance, • Generous Paid time off, • Employee referral program, • EAP Program, • Free coffee & tea daily Schivo Medical is an Equal Opportunity Employer. All qualified applicants will receive employment consideration without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.
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