Key Role: R&D Program Manager
Job Description
We are seeking a seasoned R&D Program Manager to oversee the successful delivery of projects within our R&D/Product Development functions. The role reports directly to the VP of R&D and is responsible for managing project activities from clinical and commercial approval.
Responsibilities
1. Develop innovative products that meet customer, patient, and business needs.
2. Lead projects as Project Lead, developing plans and goals that align with company objectives.
3. Design project plans, timelines, budgets, and resource requirements, and communicate these to stakeholders.
4. Translate project plans into work packages for team members and collaborate with management to ensure project goals are met.
5. Apply strong project management skills to lead cross-functional projects, ensuring timely and budget-friendly delivery.
6. Support team members in executing tasks and delivering project outcomes throughout the design development cycle.
7. Communicate effectively with internal and external stakeholders to gather project inputs, manage expectations, and provide progress updates.
8. Demonstrate collaborative leadership, fostering collaboration across multiple functions beyond R&D.
9. Cultivate a positive team culture to drive high-performance engineering teams where individual contributions exceed collective output.
10. Manage relationships with external vendors/partners to support product development activities.
11. Implement robust engineering practices and processes to ensure reliable and high-quality products.
12. Ensure test plans and testing align with regulatory requirements.
13. Prepare regulatory submission-ready documentation for FDA and other authorities.
14. Contribute to clinical activities, including limited case support, and investigate root causes of identified product failure modes.
15. Develop and maintain the company's IP portfolio.
16. Mentor senior and R&D engineers without direct supervisory authority.
17. This role may involve supervising junior engineers or technicians.
Requirements
* Minimum Bachelor's degree in Mechanical or Biomedical Engineering or related field.
* At least 7 years' experience in medical device product development with a minimum of 3 years in project management/leadership roles for technical projects across R&D and Manufacturing.
* Proven track record in planning and resource management to meet defined project goals, risk control, and certification (PMP or Prince2).
* Deep understanding of FDA and ISO 13485 requirements, with ability to interpret and implement them.
* Experience with EU Medical Device Regulation and MEDDEV guidance documents.
* Knowledge of design, verification, and process validation processes.
* Prior experience in GMP, process validation, change control, CAPA, and electronic document control systems.
* Broad knowledge of materials and manufacturing processes applicable to the medical device industry.
* Experience working with subcontract manufacturers/suppliers/test facilities.
* Previous experience in preparing regulatory submissions.
* Excellent communication, organizational, and time management skills.
* Good problem-solving mindset.
* Leadership and project management skills with ability to build and manage a small team.
* Strong verbal and written communication skills.
* Able to thrive in a start-up environment and deliver results in low-structured environments.
For More Information
Contact James Cassidy or call in confidence at specified number.