Mechanical Engineer – Medical Device Design

At StarFish Medical, we partner with innovative companies to develop breakthrough medical technologies that improve lives around the world. We’re seeking a hands-on, creative, and highly skilled Mechanical Engineer to join our Irvine team.

Reporting to a Mechanical Engineering Team Manager, you will help develop cutting-edge products that add to Starfish Medical’s world-renowned medical device portfolio. You will help define the mechanical elements of the system architecture in collaboration with a talented multidisciplinary design team, and take ownership of the mechanical design of that system, with an eye toward design for manufacturing and assembly. You will be expected to communicate design decisions to secure client buy-in and to conduct and report on testing to verify that the design meets the requirements.

Location

StarFish Medical, Irvine, CA (On-Site)

Salary

Base Salary: USD 105,000 – 131,300

Annual variable compensation: Target of 3-8% of base salary, tied to goal achievement

Additional Compensation: Employees are eligible for a profit-sharing program

Benefits of working at StarFish Medical

Becoming a part of a group of passionate individuals striving to make a meaningful impact, combined with:

• Make a meaningful impact through life-changing medical technologies
• Excellent benefits package for you and your family
• Profit-sharing program
• Monthly all-hands meetings and open communication culture
• Active social committee with events during work and outside hours. Some for individuals, some for families
• 401(k) participation
• Vacation and sick days

What You’ll Do

• Determine design requirements from information provided by clients and/or project managers and help fill in gaps where design requirements are vague or missing by performing additional testing or investigation
• Efficiently analyze problems and synthesize your experience and breadth of knowledge of engineering fundamentals into a solution that meets design requirements
• Develop novel mechanical designs for complex medical devices and systems through brainstorming, architecting, and engineering solutions that balance cost, performance, and complexity while considering the optimal solution from the perspective of the entire system
• Design products for manufacturing, assembly, and test using your broad knowledge of materials and manufacturing processes
• Follow best practices to create robust 3D models and drawings of designs in SolidWorks that are easily modified and maintained
• Maintain revision control of the models and drawings using SolidWorks PDM
• Find, build relationships with, and help qualify vendors who can partner with us to make high-quality prototypes quickly and who can become part of the production supply chain
• Interface with vendors and internal supply chain and accounting resources to get quotes and procure prototype parts that meet specifications within quoted lead times
• Design and build assembly tools and fixtures, and assemble prototypes
• Create test plans, write test protocols, execute testing, and write detailed test reports to select the most appropriate design path and to perform design verification
• Perform failure analysis of prototypes that have failed in test to identify the root cause and open the door for identifying design changes that will be effective in passing the test
• Create and maintain a design documentation package that is suitable for manufacturing transfer and regulatory submission by complying with quality system requirements and FDA design controls

What You Bring

• A bachelor’s degree in mechanical engineering
• 5 or more years of experience in product development
• Demonstrated proficiency with SolidWorks
• Excellent hands-on skills for prototype building and testing
• Knowledge of standard manufacturing processes such as CNC machining, sheet metal, injection moulding, etc. and experience designing parts to be made using these processes
• Strong verbal and written communication skills to be able to report out on project status and manage client expectations

Preferred Qualifications

• A master’s degree in mechanical engineering or another advanced engineering degree
• Experience working on interdisciplinary electromechanical product development projects, and a basic understanding of electrical design and electronics
• Experience working under FDA design controls or in another regulated environment (ISO 13485, ISO 9001, AS9100, etc.)
• Experience working in a project-based consulting environment
• Experience with project planning and management
• Experience performing finite element analysis to optimize structural strength, thermal management, fluid flow, etc