Senior R&D Engineer – Instruments

Senior R&D Engineer – Instruments

Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field, and a minimum of 5 years of medical device experience, OR
• Advanced degree in a related field and a minimum of 4 years of medical device experience
• Understanding of medical device regulations, including ISO 13485 and FDA 21 CFR Part 820.
• 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 two or more of the following key areas: injection molding, 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.
• Experience in product development within regulated industries and knowledge of sterilization and biocompatibility testing.

Responsibilities

• 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.

Preferred Qualifications

No preferred qualifications provided.