As the Program Manager for our product pipeline, you will play a pivotal role in driving the successful development, manufacturing, and commercialization of our innovative products. You will be responsible for leading cross-functional teams, ensuring the timely completion of projects, and delivering high-quality products that meet regulatory standards. This role requires a hands-on approach, where you will act as a "player coach," leveraging your experience as an R&D engineer to provide technical guidance and support to your team.
Responsibilities
- Lead the end-to-end project management of orthopedic implant development and commercialization, ensuring adherence to timelines, budgets, and quality standards.
- Collaborate with cross-functional teams including R&D, regulatory affairs, quality assurance, and external suppliers to ensure alignment and successful project execution.
- Develop and maintain project plans, schedules, and budgets, identifying risks and implementing mitigation strategies to ensure project success.
- Provide guidance and support to the team throughout the product development lifecycle.
- Drive continuous improvement initiatives to optimize processes, increase efficiency, and streamline best practices.
- Ensure compliance with relevant regulations and standards, such as FDA guidelines and ISO requirements.
- Foster a collaborative and positive team environment, promoting effective communication, knowledge sharing, and cross-functional collaboration.
Qualifications
- Bachelor's degree (Level 8) in Engineering, Science, or a related field.
- Minimum of 5 years of experience in the medical device industry, with a focus on orthopedic implants.
- Demonstrated experience leading projects from inception to commercial launch, with a track record of successful project delivery.
- Strong understanding of the product development lifecycle and experience working within a regulated environment (FDA, ISO, etc.).
- Proven ability to effectively lead cross-functional teams, fostering collaboration and driving performance.
- Excellent communication skills, with the ability to convey complex technical concepts to both technical and non-technical stakeholders.
- PMP certification is preferred, showcasing a solid foundation in project management principles and best practices.
- Strong analytical and problem-solving skills, with a keen attention to detail.
- Results-oriented mindset with a sense of urgency, while maintaining a high level of quality in deliverables.
Please Contact
Phil Kemp
Chief Operating Officer
philip.kemp@x-bolt.com
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