Early stage company developing groundbreaking solutions for nonaddictive, non-pharmaceutical management of pain. Ongoing clinical trials of the firm’s combinatorial device have shown great promise in treating post operative pain without opioids or other drugs. This hands-on role offers engineering and scientific challenges in a fast-paced, collaborative environment that provides significant opportunity for growth. The technology was spun off from an acclaimed lab at Massachusetts General Hospital that has developed significant medical technologies that have become highly successful commercial entities. It was founded by individuals and investors with great success in the medical device industry and decades of combined R&D and industrial experience.
We are seeking a successful, industry experienced product development engineer or scientist to work closely with the executive team to help bring a concept from prototype to commercialization. The candidate should be familiar with viscous fluids or mixed materials and single use medical devices that enable their effective delivery.
The seasoned engineering leader in this hands-on position will apply his or her expertise in fluidics, process development and optimization of medical device designs and/or liquid pharmaceuticals. The role involves contributions at all levels of the device’s development, including design inputs and outputs, risk management, V&V, design control and transfer, and manufacturing.
Essential Duties and Responsibilities:
- Lead a talented, highly motivated and focused team’s development activities including:
- Concept optimization
- Detailed design and documentation
- Design transfer
- Scale-up for commercialization
- Interface with outside consultants, vendors, and contract manufacturers.
- Collaborate with the clinical team to support clinical studies and commercialization activities.
Required Education, Experience, Skills and Knowledge:
- MS or PhD in mechanical, chemical, or biomedical engineering, chemistry, physics or applicable disciplines applicable. A BS and especially relevant training will also be considered.
- At least five years of experience in medical devices and/or pharmaceutical development that involves delivery of liquid formulations.
- Experience with injectable medical products, fluid dynamics, and heat transfer is preferred.
- Experience with formulation and optimization for injection is strongly preferred, such asnviscous fillers, (hyaluronic acid, liquid polymers, etc.) or mixed material (bone cement, slurries, liposomal solutions, etc.)
- Hands on experience with design controls (21 CFR 820.30) and risk management (ISO14971) is desired.