Suna Solutions · 23 hours ago
Electro Mechanical Engineer
San Diego, CA
Full-time
Onsite
Senior Level, Lead/Staff
$120K/yr - $150K/yr
10+ years expSuna Solutions is an innovative medical device company seeking a Senior Electro-Mechanical Design Engineer. In this role, you will be responsible for the design process from concept to production, ensuring that innovative solutions meet the highest standards of safety, functionality, and regulatory compliance.
DeliveryHuman ResourcesInformation Technology
Hiring Manager
Rajesh Kumar
Responsibilities
Design and development of complex electro-mechanical medical devices using SolidWorks and Altium Designer software
Translate engineering requirements into innovative and manufacturable designs
Perform advanced design calculations and analyses to verify product performance, reliability, and regulatory compliance
Independently select, specify, and source electrical and mechanical components for optimal functionality
Champion design control principles and ensure meticulous adherence to ISO 13485 quality management system throughout the entire development lifecycle
Hands-on mechanical and electrical assembly, testing for verification & validation (V&V) activities for prototypes and first articles
Mentor and guide other engineers, fostering a collaborative and supportive design environment
Prepare detailed design documentation, including drawings, specifications, bill of materials, and reports
Participate in design reviews, presenting findings and recommendations to cross-functional teams (engineering, quality, regulatory)
Stay up-to-date on the latest advancements in medical device technology and relevant regulatory requirements
Other duties as assigned by management
Qualification
Required
Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related field
10+ years of experience in electro-mechanical design for the medical device industry
Proven track record of successfully leading and completing complex medical device design projects
Proven experience using SolidWorks, PDM, and Altium Designer CAD software
In-depth understanding of design control principles and ISO 13485 quality management system
Experience with various fabrication processes (plastic injection molding, sheet metal, printed circuit board fabrication, and assembly)
Experience with small motor-driven mechanisms and small air pump delivery systems
Experience with Design for Manufacturing and Assembly (DFMA) principles
Experience working with a variety of medical device materials and manufacturing processes
Familiarity with risk management processes (FMEA, FTA) in a medical device environment
Strong analytical and problem-solving skills with a focus on innovative solutions
Excellent project management skills with the ability to prioritize and manage multiple tasks effectively
Strong leadership and communication skills, adept at working collaboratively in a cross-functional environment
Excellent written and verbal communication skills, with the ability to prepare clear and concise technical documentation
Meticulous attention to detail and a strong commitment to quality
Ability to work independently and take ownership of projects
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), MS Teams, and proficient in utilizing Gant charts for project management
Company
Suna Solutions
Suna Solutions is a staffing and recruiting company offering temporary staffing services.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase