Principal Mechanical Engineer, Medical Device

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:

We are seeking a highly experienced and innovative Principal Mechanical Engineer in our San Diego office to lead the design and development of next-generation medical devices focused on diabetes care. This role is critical in advancing our mission to improve the lives of people with diabetes through cutting-edge technology, including insulin delivery systems, continuous glucose monitors (CGMs), and wearable therapeutics.

Responsibilities:

In the Principal Mechanical Engineer role, you are expected to conduct yourself in the manners listed below and refine any needed skills to efficiently cover all responsibilities.

• Lead mechanical design and development of medical devices.
• Manage and facilitate client interactions with clear communication as it relates to deliverables, design reviews and deadlines.
• Drive innovation in miniaturization, biocompatibility, and user-centered design for wearable and implantable devices.
• Conduct feasibility studies, risk assessments, and design verification/validation activities.
• Ensure compliance with FDA, ISO 13485, and other relevant regulatory standards.
• Mentor junior engineers and provide technical leadership across projects.
• Lead, advise, or assist in the creation of the entire product documentation for manufacturing and assembly processes in accordance with Goddard practices.
• Design and develop precision mechanical products utilizing injection molding plastics, machining, casting, laser cutting and welding, and 3D printing.
• 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.
• Lead and 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.
• Plan and execute formal verification testing, including test method development, test method validation, data analysis, and design of experiments.
• Remain apprised of the progress of certain projects, paying particular attention to any developing problems, and participate in major problem resolutions.
• Communicate to senior management any significant project risks or deviations from the plans.
• Travel as needed (valid driver’s license and vehicle required).
• Keep all privileged information private and confidential.

Business Development Assistance/Support:

• Work with business development to collect and review requests for proposals or request for support on a time and material or project basis. Ascertain project requirements or qualifications necessary for client support.
• Define project scope including proposal composition, lead and deliver presentations, estimate and stabilize the most appropriate process and deliverable to satisfy client needs.

Qualifications:

• Bachelor’s or Master’s degree in Mechanical Engineering or related field.
• 10+ years of experience in mechanical design, with at least 5 years in medical devices.
• Proven track record in developing Class II or III medical devices, preferably for diabetes management and wearable therapeutics.
• Expertise in CAD tools (e.g., SolidWorks, Creo), FEA, and tolerance analysis.
• Strong understanding of materials science, fluid dynamics, and thermal management.
• Experience with human factors engineering and usability testing.
• Excellent communication, leadership, and project management skills.

Preferred Experience:

• Experience with insulin pumps, CGMs, or other diabetes-related technologies.
• Familiarity with wearable device design and microfluidics.
• Knowledge of wireless communication and integration with mobile health platforms.
• Experience managing a team of engineers.

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.

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