Project Development Manager - Medical Devices

Job Description

Job Description

Job description

Position Overview :

We are seeking an experienced  R&D Manager / Director  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, 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 to  FDA ,  ISO 13485 ,  MDD / MDR and other standards  in 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 for  FDA 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 / 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.
• 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 in  Biomedical Engineering ,  Mechanical Engineering ,  Electrical Engineering , or a related field. A Ph.D. is a plus.
• Experience :
• 10 years  of experience in the  medical device industry , with at least  5 years  in R&D leadership roles (Manager / Director).
• Extensive hands-on experience in the development of  Class I and Class II medical devices , including devices like  RF 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 managing  cross-functional teams ,  complex projects , and meeting  regulatory requirements .
• Experience in managing relationships with  domestic and international vendors and suppliers  in the medical device supply chain.
• Skills and Competencies :
• Expertise in medical device  design controls ,  risk management , and  validation / verification  processes.
• In-depth knowledge of regulatory standards such as  FDA 510(k) ,  ISO 13485 ,  IEC 60601 , and other applicable medical device regulations.
• Strong project management skills, including the use of tools like  MS Project ,  JIRA , or similar software.
• Excellent  communication ,  leadership , and  problem-solving  skills, with the ability to manage a diverse team and collaborate across multiple departments.
• Supplier and vendor management  experience, 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 :

Benefits :

Job Type : Full-time

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

Benefits :

Schedule :

Ability to Commute :

As a global company, elliquence educates physicians on the least invasive procedural solutions for spine pathology and provides our unique and specialized tools to support these procedures. The procedures are truly the least invasive solutions available today, and generally begin with targeting the spinal anatomy with a spine needle. Our tag line, “Less is More” is the absolute truth.

What we offer :

Base salary and annual performance-based bonus.

Medical, dental, vision and life insurance

401(k)

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Salary : $150,000 - $175,000