Mechanical Engineer II, Medical

Our Mission:

Through inspired engineering and design, we deliver outstanding solutions that positively impact lives. We use an interdisciplinary development process that combines our diverse engineering experience with creative industrial design solutions. We succeed when our partners succeed - it’s all about solving the most complex challenges by creating transformative technology.

Our Culture and People:

At Goddard, our most important asset is our people. We don't just work together; we thrive together. We foster a culture of collaboration, continuous learning, and mutual support. We believe in taking exceptionally good care of each other because great teams build great solutions. If you are someone who embodies the values of accountability, inspiration, dedication, efficiency, innovation, integrity, quality, and reliability, we want you on our team. Come be a part of a workplace where your ideas are valued, your growth is encouraged, and your contributions make a real impact. Join us in shaping the future of transformative technology - together.

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

• Buildprototypes and iterate quickly to derisk design direction

• Ability totrack toa budget. Knowing“what good looks like” and when to stop iterating to conserve client funds

• Plan and execute lab notebook studies,pre-verificationstudies, and design verification testing. Get buy in from cross functional groups with conflicting priorities

• Create models inSolidworksand 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 orassistin 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 resolvetechnicalconflictsbetween clients and engineering teams

• Supportprioritizationand 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 plansand 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 onmedical 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 packageand 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, Goddardoffer6 weeksfully 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