We are seeking an experiencedProduct Development Managerwith a strong background in engineering and project management to lead the development and innovation ofClass I and Class II medical devices, particularly in the areas ofRF generators, RF electrodes, endoscopic instruments, endoscopes, and drill systems. The ideal candidate will have significant expertise in medical device development, regulatory compliance, cross-functional project management, and supplier development and collaboration. Proven leadership skills are essential, as the role will also involve working with internal engineering team and both domestic and overseas vendors to ensure the successful execution of projects.

Key Responsibilities:

• Leadership and Team Management:
• Lead and mentor a multidisciplinary team of engineers and technicians to deliver high-quality medical devices on time and within budget
• Foster a culture of collaboration, innovation, and continuous improvement within the R&D department
• Provide regular updates to senior management on project status, risks, and milestones
• Product Development:
• Manage the end-to-end development cycle of Class I and Class II medical devices from concept to commercialization, ensuring adherence to design controls and quality standards
• Oversee the design, prototyping, testing, and validation of medical devices, including RF generators, electrodes, endoscopes, drill systems, instrumentation, etc
• Ensure compliance with FDA, ISO, IEC, and other relevant standards and regulations in different countries worldwide during the product development process
• Project Management:
• Plan, execute, and track R&D projects, ensuring timely delivery, meeting product specifications, and adhering to budgets
• Develop and maintain detailed project schedules, resource plans, and risk management plans
• Act as a liaison between R&D, quality assurance, regulatory affairs, manufacturing teams as well as external suppliers/ vendors to ensure smooth project execution
• Regulatory Compliance and Documentation:
• Ensure all product development activities adhere toFDA,ISO 13485,MDD / MDR and other standardsin different countries / regions worldwide
• Prepare technical documentation (e.g., design history files, risk management files, and verification/validation protocols) for regulatory submissions
• Work closely with regulatory affairs to prepare submissions forFDA 510(k)or other regulatory approvals for medical devices
• Innovation and Technical Expertise:
• Contribute to the strategic direction of product innovation, focusing on cutting-edge technologies
• Drive the research of new materials, components, and manufacturing techniques to improve product performance, reduce costs, and ensure patient safety
• Troubleshoot complex engineering problems and provide solutions to overcome technical challenges during development
• Cross-Functional Collaboration:
• Collaborate with cross-functional teams, including marketing, sales, quality assurance, and manufacturing, to ensure the final product meets market needs and regulatory requirements
• Participate in design reviews, risk management sessions, and FMEA (Failure Modes and Effects Analysis) to ensure design robustness and patient safety
• Supplier and Vendor Management:
• Collaborate with domestic and overseas vendors/suppliersto identify, develop, and deliver necessary components, materials, and technologies for medical device projects
• Manage relationships with external suppliers and vendors, ensuring compliance with product specifications, quality standards, timelines, and cost structures
• Lead efforts for thesearch and evaluation of new or suitable suppliers/vendorsto ensure access to high-quality materials, innovative technologies, and competitive pricing for product development
• Monitor supplier performance and resolve issues related to quality, delivery, or compliance, ensuring minimal impact on project timelines and objectives
• Coordinate with suppliers to ensure that design requirements are communicated and met, and that all necessary certifications and documentation (such as material safety data sheets, regulatory approvals, etc.) are provided
• Continuous Improvement:
• Stay current on industry trends, emerging technologies, and best practices related to medical devices, specifically in Class I and Class II devices
• Continuously improve R&D processes, tools, and workflows to enhance productivity and the quality of product deliverables
  
  

Qualifications:

• Education:
• Bachelor’s or Master’s degree inBiomedical Engineering,Mechanical Engineering,Electrical Engineering, or a related field. A Ph.D. is a plus
• Experience:
• 10+ yearsof experience in themedical device industry, with at least5 yearsin R&D leadership roles (Manager)
• Extensive hands-on experience in the development ofClass I and Class II medical devices, including devices likeRF generators, RF electrodes, intrumentation, endoscopes, and drill systems
• Strong background in engineering disciplines such as electrical, mechanical, and/or biomedical engineering with expertise in medical device design and development
• Proven track record of managingcross-functional teams,complex projects, and meetingregulatory requirements
• Experience in managing relationships withdomestic and international vendors and suppliersin the medical device supply chain
• Skills and Competencies:
• Expertise in medical devicedesign controls,risk management, andvalidation/verificationprocesses
• In-depth knowledge of regulatory standards such asFDA 510(k),ISO 13485,IEC 60601, and other applicable medical device regulations
• Strong project management skills, including the use of tools likeMS Project,JIRA, or similar software
• Excellentcommunication,leadership, andproblem-solvingskills, with the ability to manage a diverse team and collaborate across multiple departments
• Supplier and vendor managementexperience, with the ability to assess and select new suppliers, manage performance, and resolve any supply-related issues efficiently
• Certifications:
• PMP(Project Management Professional) certification is a plus but not required
• CQE(Certified Quality Engineer) or other relevant certifications in medical device quality and compliance are advantageous
  
  

Additional Skills:

• RF Engineering Knowledge: Familiarity with RF energy applications, design considerations for RF generators and electrodes, and related technologies in the medical device space
• Endoscopic Technologies: Experience with endoscopic instrument design, optics, and surgical tool integration
• Material Science: Knowledge of biocompatible materials and component selection for medical devices, particularly for implantation or prolonged exposure to the human body
  
  

What we Offer:

Pay: $150,000.00 - $175,000.00 per year

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance
  
  

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
  
  

Location:In person (Baldwin, NY)

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