Principal Engineer, Manufacturing & Sustaining Engineering

at  Magnolia Medical Technologies

Principal Engineer – Manufacturing & Sustaining Engineering
Magnolia Medical Technologies, Inc has the unique opportunity for a Principal Engineer to join our product development team. The Principal Engineer, Manufacturing & Sustaining Engineering will be focused on executing the manufacturing transfer of our emerging products, driving Magnolia Medical’s Sustaining Engineering portfolio, and supporting Design for Manufacturability initiatives. This position serves as both a technical expert and in 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 transfer activities as the organization expands its product portfolio.
Magnolia Medical Technologies, Inc. is an early commercialization stage medical device company developing products to address challenges that plague healthcare systems globally. Our product development team is dynamic, motivated, and passionate about designing innovative products that make a difference to healthcare professionals and their patients.

Primary Responsibilities:

• Planning and engineering strategies to achieve company objectives as well as projects
• Experienced with medical device manufacturing, product development processes, statistical process controls, medical device packaging, and DFM.
• Creating and managing engineering budgets
• Define and lead company-wide projects across multiple groups / teams.
• Company role model, strengthening relationships and developing a positive team culture.
• Experienced project management and design control / stage gate development and ideation processes.
• Executes diverse engineering tasks related to the development of medical devices: from concept and development through commercialization
• Support projects in various capacities: i.e. as an individual contributor, as technical lead of a small team, or a subject-matter expert/consultant
• Incorporate Lean/6-sigma elements into product development and Design for Manufacturability activities.
• Collaborate with design & development teams to identify product improvements and manufacturing strategies
• Partners with quality and supply chain to transition component and device designs to suppliers and contract manufacturers
• Drive efforts for intellectual property strategy

Required Skills and Experience:

• BS in Mechanical Engineering, Biomedical Engineering or related field. MS in Mechanical Engineering preferred.
• Minimum ten years of engineering experience, including manufacturing process development
• Experienced with upstream valuation and concept development
• Experience leading successful project teams
• In-depth knowledge and experience with injection molding component processes
• Experience with medical device packaging and design
• Experience identifying and working with suppliers for a wide variety of medical device components
• Working understanding of FDA Quality Systems Regulations and process development within that regulated environment
• Lean/6-sigma certification
• Highly proficient CAD user, with SolidWorks preferred
• Self-motivated, ability to encourage and energize others
• Supplier Quality Management experience a plus
• Open and effective communicator

More about Magnolia Medical Technologies
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.
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.
The company has amassed an intellectual property portfolio including more than 70 issued method, apparatus and design patents with more than 50 additional patent applications pending. The total potential market for Magnolia’s technology exceeds $2.0 billion annually.
Magnolia Medical is committed to the continued development and innovation of 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.

• Planning and engineering strategies to achieve company objectives as well as projects
• Experienced with medical device manufacturing, product development processes, statistical process controls, medical device packaging, and DFM.
• Creating and managing engineering budgets
• Define and lead company-wide projects across multiple groups / teams.
• Company role model, strengthening relationships and developing a positive team culture.
• Experienced project management and design control / stage gate development and ideation processes.
• Executes diverse engineering tasks related to the development of medical devices: from concept and development through commercialization
• Support projects in various capacities: i.e. as an individual contributor, as technical lead of a small team, or a subject-matter expert/consultant
• Incorporate Lean/6-sigma elements into product development and Design for Manufacturability activities.
• Collaborate with design & development teams to identify product improvements and manufacturing strategies
• Partners with quality and supply chain to transition component and device designs to suppliers and contract manufacturers
• Drive efforts for intellectual property strateg