Product Development Manager – Medical Devices
Baldwin, NY, NY
Full Time
Manager/Supervisor
About the job
Seeking an experienced Product Development Manager with a strong background in engineering and project management to lead the development and innovation of Class I and Class II medical devices, particularly in the areas of RF 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, strong understanding of engineering, and supplier development and collaboration. Proven leadership skills are essential as the role will also involve working with our internal engineering team, cross functionally throughout the organization as well as clients and vendors both domestic and international to ensure the successful execution of projects.
Key Responsibilities:
Salary range is $150,000 - $175,000/annual
This position is full time, on-site and located in our headquarters in Baldwin, NY.
An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits.
We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws.
We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email [email protected].
Seeking an experienced Product Development Manager with a strong background in engineering and project management to lead the development and innovation of Class I and Class II medical devices, particularly in the areas of RF 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, strong understanding of engineering, and supplier development and collaboration. Proven leadership skills are essential as the role will also involve working with our internal engineering team, cross functionally throughout the organization as well as clients and vendors both domestic and international to ensure the successful execution of projects.
Key Responsibilities:
- Lead, mentor and leverage a multidisciplinary team of engineers to establish product objectives, timeline and resources while fostering a culture of collaboration innovation and continuous improvement.
- Troubleshoot/resolve issues and ensure task completion by establishing priorities validating solutions and reaching a conclusion with functional managers and team members.
- Contribute as a leader to the strategic direction of product innovation, focusing on cutting-edge technologies while providing regular updates to senior management.
- Oversee the design, prototyping, testing, and validation of medical devices, including RF generators, electrodes, endoscopes, drill systems, instrumentation, etc. Interact with clients (surgeons) and senior leadership for ensuring adherence to design controls and quality standards.
- Ensure compliance with FDA, ISO, IEC, and other relevant standards and regulations worldwide during the product development process.
- Plan, execute, and track R&D projects, ensuring timely delivery, meeting product specifications, and adhering to budgets.
- Collaborate with cross-functional teams including Marketing, Sales, R&D, Regulatory Affairs, Quality Assurance, and manufacturing, to ensure the final product meets market needs and regulatory requirements
- Prepare technical documentation (e.g., design history files, risk management files, and verification/validation protocols) for regulatory submissions
- Partner with Regulatory Affairs to prepare submissions for FDA 510(k) or other regulatory approvals for medical devices
- Drive research of new materials, components, and manufacturing techniques to improve product performance, reduce costs, and ensure patient safety
- Partner with surgeons, physicians and industry professionals for clinical and device feedback to ensure product optimization for both surgeons and their patients.
- Collaborate with domestic and international vendors/suppliers to 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 the search and evaluation of new or suitable suppliers/vendors to ensure access to high-quality materials, innovative technologies, and competitive pricing for product development
- 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
- 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
- Education: Bachelor’s or Master’s degree in Biomedical Engineering, Mechatronic Engineering, Mechanical Engineering, Electrical Engineering, or a related field. A Ph.D. is a plus
- 10+ years of experience in the medical device industry, with at least 5 years in R&D leadership roles (Manager)
- Extensive hands-on experience in the development of Class I and Class II medical devices, including devices such as RF generators, RF electrodes, instrumentation, 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
- Expertise in medical device design controls, risk management, project management, continuous improvement and validation/verification processes
- Strong understanding of engineering knowledge such as GD&T Principals and ability to read and interpret technical drawings.
- In-depth knowledge of regulatory standards such as FDA 510(k), ISO 13485, IEC 60601, and other applicable medical device regulations
- Excellent communication, leadership, and problem-solving skills, with the ability to manage a diverse team, complex projects and collaborate across multiple departments
- Supplier and vendor management experience (domestic and international), with the ability to assess and select new suppliers, manage performance, and resolve any supply-related issues efficiently
- Computer Programs: MS Office Suite, SolidWorks, Project Management Programs, AUTOCAD, Unigraphics, NX, Creo, CATIA.
- Six Sigma Belts (Green or Black preferred)
- 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
- Certifications: PMP (Project Management Professional) a plus but not required; CQE (Certified Quality Engineer) or other relevant certifications in medical device quality and compliance are advantageous
Salary range is $150,000 - $175,000/annual
This position is full time, on-site and located in our headquarters in Baldwin, NY.
An employment offer is based on the candidate's professional experience, specialty, skillset, education, geography, related licenses or certifications, and other business needs. The compensation range indicated does not include other forms of compensation or benefits.
We value the diversity of our team and inspire creativity in our innovation. elliquence proudly provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state and local laws.
We are committed to working with and providing reasonable accommodation to individuals with disabilities. If you need any reasonable accommodation due to a disability for any part of the application process, please email [email protected].
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