Senior Research And Development Engineer

Company Info:

Commercial-Stage, 200-Person Minimally-Invasive Interventional medical device company. Very well-funded with $50MM financing recently secured and next-gen products in development.

Summary:

The Instruments Engineering team is a highly energetic and actively growing team that is responsible for developing and ultimately driving instruments and accessories through to launch. In this role, you will drive the design and development of interventional flexible Endoscope/Catheter solutions for both released and next-generation critical components.

You will be immersed in a highly collaborative and multidisciplinary team, teaming up with cross-functional partners in Manufacturing, Quality, Marketing, Clinical, and Regulatory to bring these novel concepts through all phases of development to commercialization.

In this Role You Will:

• Create prototypes, design fixturing, devise feasibility studies, and execute testing to draw meaningful conclusions and guide product development.
• Ensure design and development pathways maintain adherence to the design control process, working with cross-functional partners to enable manufacturability, reliability, and scalability.
• Use SolidWorks to create well-defined models, assemblies, and engineering drawings.
• Effectively solve engineering problems through methodical root cause analysis and data-driven solution finding.
• Define qualification strategies for new designs or processes, working in partnership with other teams across the organization to gain alignment.
• Meaningfully translate customer requirements into new or revised product requirements and engineering specifications.
• Drive communication with suppliers to progress activities relevant to component or subassembly development.
• Effectively communicate project progress, results, and risks to relevant stakeholders.
• Develop and validate verification test methods, create and execute protocols, and author associated reports and risk documentation.
• Coordinate external testing activities such as sterilization, packaging, and biocompatibility testing, ensuring alignment with project goals and timelines.

Requirements:

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field, and a minimum
• 4-7+ years' medical device engineering experience
• Ability to apply DFX principles to create designs that can scale.
• Proficiency in SolidWorks and a strong understanding of design for manufacturability, tolerance stack analysis, and GD&T.
• Track record of taking design concepts from prototyping stage through to design maturation.
• Proven design capabilities in injection molding and one or more of the following key areas: electro-mechanical sub-systems, catheter construction, endoscope construction, fluidics.
• Experience creating and running simulations (CFD, FEA) to inform product development.
• Solid experience conducting structured design of experiments (DOEs) and using statistical methods to analyze data.
• Strong collaboration and communication skills, with the ability to work effectively on cross-functional teams.
• Strong problem-solving and analytical skills, with a hands-on approach to product development and testing.
• Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.

Who You Will Report To:

• Sr. Vice President, Research & Development

Must Have US Work Authorization or be a US Citizen (No Sponsorships or C2C candidates)

• Local Candidates preferred, however some assistance may be offered for well-qualified candidates from out of the area.