The Role: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).
Responsibilities: - Eager to learn, build, try things, fail, improve, and repeat
- 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
Qualifications:- 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
Our Benefits:Flexible Time Off: Benefit from our generous flexible time off policy. We also provide sick leave and bereavement time because we understand that not all time off is for fun
Retirement Savings: Invest in your future with a 401(k)-retirement plan. Goddard contributes 3% of your annual salary directly into your 401(k) account-regardless of your own contributions
Health Coverage: Access to comprehensive medical, dental, and vision insurance for you and your family. Goddard contributes 80% of monthly premiums for all medical plan options
Family Support: To take the time you need to welcome the newest member of your family, Goddard offer 6 weeks fully paid parental leave with support of PFML state programs
Company Engagement: Engage with your colleagues through a variety of regular company and team events, including weekly social hours, Athletic Club outings, and department outings
The pay range for this role is:
80,000 - 100,000 USD per year (San Diego, CA)
