Director Of New Product Development / R&D

The Director of New Product Development has full responsibility for planning, designing, and executing New Products from concept to launch, according to the company's product roadmap. This position will be responsible for coordinating development activities across internal and external stakeholders and service providers, to ensure New Products are developed on-time and within budget. Additionally, this role will be responsible for leading and executing all aspects of the Product Development process.
The individual will possess a broad range of medical device design and development experience, a record of leading teams from product concept through validation and into manufacturing/commercialization launch, and in-depth technical knowledge that relates to MMT's existing and future product portfolio. As a key member of the leadership team, this position will promote and drive innovation and excellence through cross-functional collaboration.
About Magnolia Medical:
Magnolia Medical is an early-stage rapid growth commercial-stage medical device company that is developing solutions to challenges that have long plagued our healthcare system. Our Steripath® Initial Specimen Diversion Device® for blood collection and contamination prevention has created a new standard of care for prevention of false positive blood cultures, the gold standard diagnostic test for sepsis. Steripath® delivers significant clinical and cost savings benefits which have been extensively proven with large bodies of clinical data and peer-reviewed published studies. Based on this exceptional performance profile, we have an FDA-cleared indication for reducing blood culture contamination and uniquely provide a money-back Clinical Performance Guarantee for Steripath® to our hospital customers.
With strong institutional investor backing, we offer highly committed and qualified candidates the opportunity to be a part of building a company dedicated to dramatically improving the accuracy of sepsis diagnostics to positively impact patient outcomes and hospital economics.
Key Responsibilities:

• Lead Product Development teams in the "cradle-to-grave" development of New medical devices and product line extensions, as well as design changes to existing products.
• Scope and fully plan new development projects, including budget, timeline, resources and risks. Integrate cross-functional inputs from manufacturing, quality and regulatory teams as part of the planning process.
• Support a structured approach to Product Development, with an eye for compliance with the QMS and established NPD processes.
• Lead brainstorming and design reviews; create design concepts and technology for New Products or improvements to existing products.
• Manage selection, training, development and performance management for the Product Development team. Assess and build the capability and capacity within the team.
• Direct and manage prototype manufacturing.
• Work with Operations to ensure smooth technology transfer and scale-up to commercial scale.
• Collaborate closely with Project Management to ensure structured processes are in place.

Required Skills and Experience:

• 10+ years of medical device Product Development leadership experience.
  • Strong expertise with high volume, disposable medical devices.
• Bachelor's degree required. Master's degree preferred.
• Demonstrated experience in transitioning medical device Product Development programs to commercial manufacturing.
• Strong project leadership skills. Ability to prioritize and manage multiple projects/initiatives in a timely and cost-effective manner.
• Experienced and skilled in building, leading and mentoring teams.
• Knowledge of medical device regulations (FDA, MDD/MDR), and related standards (e.g., ISO 13485). Experience with 510K and CE mark.

About Magnolia Medical Technologies, Inc.
Magnolia Medical Technologies develops, manufactures and markets innovative blood and bodily fluid collection devices to facilitate significant improvements in the accuracy, consistency and predictability of critical laboratory tests for patients in hospitals.
Dr. Richard Patton, the company's co-founder, invented and patented the Initial Specimen Diversion Technique (ISDT™) and Initial Specimen Diversion Device (ISDD®) for blood culture collection and contamination prevention, and authored the seminal peer-reviewed publication on the efficacy of this technique the Journal of Clinical Microbiology in 2010.
The company's flagship product, Steripath® Initial Specimen Diversion Device® for blood culture collection and contamination prevention, has been clinically proven in over 20 studies including 8 peer-reviewed publications in leading medical journals to virtually eliminate the preventable error of blood culture contamination and false positive results for the diagnosis of sepsis. Steripath delivers reductions in false positives of up to 92% with 12-month sustained contamination rates as low as 0.2% and an average cost savings of ~$1M a year for a typical US hospital.
Magnolia is establishing the new standard for blood culture integrity and sepsis testing accuracy and has effectively executed against its mission to change national blood culture collection guidelines and contamination benchmarks through CDC, CLSI and NQF.
The company has amassed an intellectual property portfolio including more than 125 issued method, apparatus and design patents with more than 50 additional patent applications pending. Magnolia Medical is committed to the continued development and successful marketing of innovative products that will transform the way healthcare is practiced around the world. The company supports this effort by offering competitive compensation, incentive packages, benefits and career growth opportunities to the most qualified candidates in the marketplace.
Magnolia Medical Technologies, Inc. is an equal opportunity employer.
For more information, visit magnolia-medical.com
* Must be willing to submit to a criminal background check upon offer of employment.
** As a condition of employment with Magnolia Medical Technologies, you are required to provide proof that you are fully vaccinated against COVID-19 or qualify for a reasonable accommodation.