Sr. Director of R&D
3 weeks ago
Position Summary:
In this leadership role, you will be tasked with overseeing and guiding a group of engineers within our Research & Development department, focusing on product development within the realm of medical device manufacturing. Offer technical guidance and allocate tasks to the team, all while maintaining a hands-on approach and the capacity to successfully finish projects. Collaborate with Regulatory, Manufacturing, Quality, Sales, and Marketing teams to ensure the timely introduction of new products to the market.
Essential Functions:
- Experience driving product development projects through all phases of development from concept to submission & launch, with proven results.
- Product life cycle: manage design control; support sustaining engineering activities; support quality assurance and regulatory activities.
- Plan and execute realization of product opportunities identified through the Strategic Development process.
- Strategize and execute product improvement activities in cooperation with Marketing, Manufacturing and Quality Assurance.
- Experience in writing requirements, Engineering Change Orders (ECO’s), design documentation, test protocols and test reports.
- Ability to effectively manage workforce, resources, and cross functional teams. Demonstrated results in dynamic environment and multiple priorities. Demonstrated teamwork abilities and hands-on style.
- Critical thinking and analytical skills, to focus on the most important product features, and provide root cause analysis and mitigation direction for the team.
- Responsible for department budget, personnel recruitment, training and development.
Other Responsibilities:
- Position will be required to perform other duties as requested, directed or assigned.
- May require domestic and international (including China) travel.
Education, Experience and skills required:
- Bachelor's degree in Engineering Discipline, Engineering or related field with a minimum of 8 plus years of relevant experience.
- Experience with all phases of development for medical devices in a FDA regulated environment.
- Knowledge/exposure to Design Control for Medical Devices, ISO standards, System Engineering, Project and Product Management
- Understanding/Background in CGMP (Certified Good Manufacturing Practices).
- Excellent verbal, interpersonal and communication skills.
- Ability to think strategically and execute methodically.
- Strong presentation skills
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