Mechanical Engineer II, Medical

Goddard•San Diego, CA

31d•$80,000 - $100,000•Hybrid

About The Position

The Mechanical Engineer II will have 3-5 years of experience in medical devices, product development, mechanical design, and engineering. This role will be part of a team of engineers to execute projects, ensuring on-time submission of deliverables. This is a hands-on position that will require, on average, 3-4 days per week in office (either in SD office or a local client site).

Requirements

3-5 years of experience in medical devices, product development, mechanical design, and engineering
Positive attitude, hunger to learn and grow
Bachelor’s degree in mechanical engineering or related field
Proven experience in one or more of the following industry segments: Neurology, Cardiovascular, Orthopedics, Women's Health, and Diabetes
Hands on medical device test experience
Functional knowledge of FDA design controls 21 CFR Part 820 and recognized standards such as ISO 13485 and 14971 and IEC 60601
Proficiency in SolidWorks CAD package and PDM
Working knowledge of common sterilization methodologies, biocompatibility, sterile packaging, shelf-life, and simulated distribution validation testing
2D drawing creation, GD&T, tolerance analysis
Strong teamwork, interpersonal and communication skills, and a demonstrated ability to work at a high level of performance both independently and collaboratively
Hands-On medical device manufacturing experience

Responsibilities

Build prototypes and iterate quickly to derisk design direction
Ability to track to a budget. Knowing “what good looks like” and when to stop iterating to conserve client funds
Plan and execute lab notebook studies, pre-verification studies, and design verification testing. Get buy in from cross functional groups with conflicting priorities
Create models in Solidworks and work within the Goddard or client PDM
Contribute to client interactions with clear communication to deliverables, design reviews and deadlines
Work independently or as part of a team to create mechanical concepts for overall packaging strategies, mechanisms, and parts while balancing function, appearance, form, and budgetary requirements
Provide DFX expertise to ensure designs are optimized
Support or design and develop precision mechanical products utilizing injection molding plastics, machining, casting, laser cutting and welding, extrusion and 3D printing
Execute iterative development cycles using rapid prototyping, root cause analysis, tolerance stack analysis, FEA, concept down-selection tools, or other engineering methods
Create or assist in Document Design History File development activities including but not limited to Design and Development planning, system requirements, RISK management, hazard analysis, xFMEA, design inputs and outputs, test plans, protocols and reports
Work with team members to resolve technical conflicts between clients and engineering teams
Support prioritization and design decisions between interdisciplinary team members including electrical engineers, software engineers, human factors engineers, systems engineers and industrial designers
Operate within a Quality Management System as well as contribute to continuous improvement efforts
Remain apprised of the progress of certain projects, paying particular attention to any developing problems, and participate in major problem resolutions
Communicate to management any significant project risks, deviations from plans and proposed solutions to course correct
Travel as needed (valid driver’s license and vehicle required)
Keep all privileged information private and confidential