COMPANY SUMMARY Laplace Interventional Inc. is medical device startup company in Minnesota focused towards development of a novel tricuspid valve prosthesis that is percutaneously delivered. The company is well backed and has recently closed its Series B funding.
POSITION TITLE : R&D Engineer (Senior/Principal)
REPORTING TO : R&D Director
POSITION SUMMARY This candidate will play a key role as part of the R&D team in the design and development of a novel transcatheter tricuspid valve. Successful candidate will play a key role on cross-functional product development team focusing on design, development, and testing in preparation for successful clinical feasibility.
RESPONSIBILITIES Work with R&D and Therapy Development teams to develop clinically representative models to assess prosthetic valve function/performance, including prototyping prosthetic valve changes Participate in brainstorming and problem-solving activities to evaluate and understand bench and field observations for continuous improvement. Work on Engineering projects associated with Valve frame and frame covering design to insure long term durability under in vivo cardiovascular conditions. Utilize engineering methodologies to understand key Valve performance metrics under normal and beyond normal operating conditions. Setup, perform and monitor valve testing valve tests required per ISO 5840 including development of novel test methods unique to Laplace's design. Participate in Physician and KOL engagement activities in converting clinical inputs to engineering inputs. Define Valve design requirements, risk controls, and develop test methodologies to assure the Valve meets defined requirements and risks have been mitigated (DFMECA) Perform qualifications on the test methods to ensure they meet international standards and manage test executions. Work with external suppliers, machine shops and/or contract manufacturers to build R&D prototypes and test equipment. Track and communicate development status, including technical issues, resource issues, schedule risks as well as mitigation plans for all. Comply with applicable FDA and international regulatory laws/standards. Maintain the lab space, keeping benches, equipment and materials organized and ready for use. Support and collaborate with engineers in resolving design and process related challenges. Order lab supplies and materials used for both research and development activities. KNOWLEDGE, SKILLS AND ABILITIES: Extremely hands-on and very comfortable with "tinkering".
Familiarity with cardiovascular and heart anatomy beneficial. General understanding of material science (material selection, stress/strain diagrams, annealing/tempering, coatings, biological material, and/or metal alloys such as Nitinol, etc.). Previous experience with Prosthetic Valve Design & Manufacturing beneficial. Strong mechanical design skills including prototype development, test method, and test-fixture design and building. Can coordinate and execute multiple activities at the same time to support project goals. Willingness to be flexible, team oriented and open minded to new processes or changes in direction. Effective utilization and development of internal and external product development resources Design software skills (SolidWorks, Fusion 360, or others) required. Familiarity with volume reconstruction from CT data using software (MIMICS, 3Mensio, or others) beneficial. PERSONAL ATTRIBUTES: Strong appetite and willingness to learn new things Mechanical inclination or intuitiveness Creative problem identification and problem solving Driven - approaches activities with a sense of urgency and ownership Flexible and adaptable Strong communication skills EDUCATION AND EXPERIENCE REQUIREMENTS: Minimum of B.S. or equivalent in mechanical or biomedical or aerospace engineering. Masters or Ph.D. degree beneficial Minimum 4-7 years in Engineering capacity Member of development team on completion of at least one implantable project from concept to clinical use Self-expanding deployable metal implant design experience (stent, valve). Verbal and written communication skills sufficient to plan and coordinate work, write detailed work instructions. Compensation shall include a market competitive salary, benefits (including medical, dental and 401(k) plan) as well as stock options in the company. If interested in the opportunity, please reach out to: .
