Job Description

Position Summary:  

This leadership role is critical in driving innovation, overseeing product development, and leading a team of engineers to excel in a dynamic medical device manufacturing environment. The Director or VP of Product Development will apply intellectual capacity, mechanical engineering expertise, and strong problem-solving skills to deliver impactful solutions. Blending strategic vision with hands-on leadership, this position inspires collaboration and motivation to ensure the timely delivery of high-quality, market-leading products. The ideal candidate will demonstrate a proven history of leading product development initiatives that achieved successful market launches and contributed to business growth.

Essential Functions:

• Lead Product Development: Successfully drive product development projects through all phases—concept, design, regulatory submission, and market launch demonstrating proven results in mechanical product design and innovation.
• Product Life Cycle Management: Oversee and manage the entire product life cycle, including design control, sustaining engineering activities, and quality assurance, to ensure products meet compliance and market needs.
• Strategic Execution: Develop and execute plans to realize product opportunities identified through the Strategic Development process, ensuring alignment with organizational goals.
• Continuous Product Improvement: Strategize and implement product enhancement activities in collaboration with Marketing, Manufacturing, and Quality Assurance teams to improve performance and customer satisfaction.
• Hands-On Leadership: Actively engage with the engineering team in prototyping, testing, and refining products to ensure the highest quality and functionality.
• Team and Resource Management : Effectively lead, mentor, and coach cross-functional teams, allocate resources, and manage a dynamic workforce to deliver results in a fast-paced environment with multiple priorities. Foster a collaborative, hands-on work culture that encourages professional development and innovation.
• Problem Solving and Innovation: Apply critical thinking and analytical skills to resolve complex challenges, perform root cause analysis, and guide the team in developing and implementing effective solutions.
• Department Leadership: Oversee departmental budgets, recruit and develop top talent, and implement training programs to foster professional growth and innovation within the team. Provide mentorship and coaching to ensure the team’s success and growth.
• Collaborate with Regulatory, Manufacturing, Quality, and Sales/Marketing teams: Work closely with these teams to deliver innovative and compliant solutions.

Other Responsibilities:

• Perform additional duties as requested, directed, or assigned to support the organization’s objectives.
• Travel domestically and internationally, including to China, as required for business needs.

Education, Experience, and Skills Required:

• Educational Background: Bachelor’s degree in an Engineering discipline or a related field. Advanced degrees preferred.
• Professional Experience: Minimum of 8–10 years of relevant experience in medical device development within an FDA-regulated environment.
• Regulatory Knowledge: Strong understanding of Design Control for Medical Devices, ISO standards, CGMP (Current Good Manufacturing Practices), and System Engineering principles.
• Project and Product Management: Demonstrated expertise in managing complex projects and product lifecycles, ensuring timely delivery and compliance.
• Strategic and Analytical Thinking: Ability to think strategically, prioritize effectively, and execute plans methodically.
• Communication and Presentation: Excellent verbal, written, and interpersonal communication skills, coupled with strong presentation abilities to convey ideas clearly.

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