Senior Engineer, Product Development

Engineering · Full-time · Seattle, United States

Job description

Magnolia Medical Technologies, Inc. is an emerging growth commercial-stage medical device company developing products to address challenges that plague healthcare systems globally. Our product development group is hiring a Senior Engineer to our dynamic, motivated, and passionate team designing innovative products that make a difference to healthcare professionals and their patients. 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 exclusive 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.

The Senior Engineer will be focused on executing on new product concepts related to the expansion of our Steripath product portfolio.  This role serves as both a technical expert and a leadership role to guide staff towards successful execution of project(s). This is also an opportunity to be involved in strategic planning, project prioritization and initiation of development activities as the organization expands its product portfolio. 

Primary Responsibilities:

  • Executes diverse engineering tasks related to the development of medical devices: from concept and development through commercialization.
  • Generates concepts and principles and investigates their feasibility for current and future products. Provides conceptual modules and renderings which depict designs and alternatives and exhibit a high degree of creativity, functional simplicity and overall design excellence. Ensures designs are cost effective and meet customer requirements.
  • Applies Design for Manufacturability (DFM) and Design for Assembly (DFA) techniques on both new and existing products to produce optimal design and manufacturing solutions.
  • Provides specification analysis, component selection and product structure organization.
  • Lead Packaging Design and Process V&V activities
  • Drives the development, test, and post-launch support of graphics, labeling, packaging, and delivery of Class II Medical Devices
  • Conducts design feasibility work, including Formative and Summative Usability Studies, for specific packaging solutions.
  • Maintains a professional, cooperative relationship with KOL’s, the customer and internal disciplines in order to provide superior levels of technical service.
  • Actively manages intercompany resources and outside vendors in support of prototype fabrication, assembly, and validation testing.
  • Partners with quality and operations to transition component and device designs to suppliers and contract manufacturers.
  • Generates requirement and specifications documents, test protocols and reports. Establishes inspection criteria.
  • Experience with ISO 13485 and Class II medical device development

Required Skills and Experience:

  • Self-sufficient, ability to execute complex pieces of work in a team environment

  • Team focused, role model, leading other engineers and proactively improving project team effectiveness

  • BS in Mechanical Engineering, Biomedical Engineering or related field

  • Minimum ten years of engineering experience, including design of injection molded plastic medical devices preferred

  • Extensive knowledge of medical device packaging materials and design, including state-of-the-art packaging methods and processes

  • Hands on knowledge/experience with disposable medical device designs

  • Experience with design for assembly-automation is desirable

  • Skilled at managing projects in an engineering lead capacity. Motivates others and drives projects forward

  • In-depth knowledge and experience designing parts for injection molding

  • Familiarity with a variety of prototyping processes

  • Experience identifying and working with suppliers for a wide variety of medical device components

  • Open and effective communicator. Enjoys collaborating and working within teams

  • Highly proficient CAD user; SolidWorks skills preferred

  • Knowledgeable of statistical methods

  • Experience utilizing external test laboratories and analysis services a plus

  • Must be willing to travel up to 10% per year

More about Magnolia Medical Technologies

Dr. Richard Patton, the company’s co-founder and Medical Director, 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 this technique published in 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 17 clinical studies including 5 peer-reviewed publications to virtually eliminate the preventable error of blood culture contamination and false positive results for the diagnosis of Sepsis – delivering a reduction in false positives of up to 92% with 12-month sustained contamination rates as low as 0.2% and an average annualized cost savings of ~$1M.

Magnolia is establishing the new standard for blood culture integrity and sepsis testing accuracy with a mission to change national blood culture collection guidelines and contamination benchmarks.

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, visitmagnolia-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.*

Peers

View in org chart