Design Engineer - Medical Devices

Are you passionate about using cutting-edge technology to improve lives? We specialize in creating innovative solutions that improve patient care and enhance lives. Our growing dynamic team of professionals works across disciplines to bring ideas to life, from concept to commercialization.

At Gilero, Design Engineers draw upon technical backgrounds in mechanical engineering and medical product development to create innovative medical devices and combination products. From generating conceptual designs to building functional prototypes to supporting and manufacturing transfer, Design Engineers impact every phase of the product development process. Design engineers work closely with clients, suppliers, and internal teams to deliver high-quality, value-driven solutions to our clients' most challenging problems.

Join us in our collaborative and innovative Carlsbsad, CA environment where your contributions will make a real difference.

Responsibilities:

• Develops mechanical design of medical devices and combination products of varying complexity.
• Works closely with clients and internal teams in electrical engineering, software, manufacturing, and quality to develop products from concept through transfer to manufacturing
• Translates user and stakeholder needs into clear design requirements. Collect design inputs from clients, end users, and human factors engineering
• Generate designs for medical device and combination devices, components, and assemblies, including 3D CAD, engineering drawings, and specifications. Leverages tools and techniques common to the practice of mechanical engineering, and applies industry standards and practices
• Working closely with project management, ensures adherence to project timelines while maintaining compliance with quality standards and regulatory requirements. May act as project manager and/or technical lead for smaller, technically oriented projects
• Working closely with project management, ensures adherence to project timelines while maintaining compliance with quality standards and regulatory requirements. May act as project manager and/or technical lead for small projects
• Supports winning new business by contributing to detailed engineering proposals in conjunction with Business Development and Project Management. Leverages experience and judgement to provide estimates of time and material for all phases of the design lifecycle
• Conducts testing for engineering feasibiilty and design verification. Draft test plans and protocols, designs test fixtures and tools, performs testing, and analyzes results
• Participates in design reviews to ensure high-quality designs that comply with regulatory requirements
• Conducts root-cause analysis investigations to support design and process troubleshooting
• Conducts engineering analysis to inform designs and determine specifications, including tolerance analysis, structural analysis, thermal and fluid analysis, etc., and generates reports summarizing findings. May use computational methods and tools to assist in analysis
• Selects and evaluates appropriate materials to meet design requirements
• Optimizes designs for cost, performance, and manufacturability

Skills/Qualifications:

• BS in Engineering or equivalent technical degree
• 1+ years relevant working experience in product development, 2+ preferred. Medical device or combination product experience preferred
• Ability to work independently and in teams to find creative solutions to engineering challenges.
• Can distill complex problems into discrete, well-defined tasks and drive to completion
• Ability to interpret and apply GD&T to engineering designs
• Experience with design for various manufacturing processes, including injection molding, machining, sheet metal, etc. Experience with injection molding plastics and silicones highly desired
• Familiar with standards applicable to the engineering discipline and medical device industry (ASME,ISO, AAMI, IEC, etc.)
• Experience with product development within a regulated industry. Familiarity with medical device regulations (FDA, ISO, etc) highly desired.
• Experience working with 3D CAD modeling software (e.g., Solidworks). Familiarity with PDM and PLM software desired.
• Experience with hands-on fabrication using machine tools, hand tools, and rapid prototyping processes.
• Excellent communication skills (oral and written). Communicates effectively with engineers, leaders, clients, partners, and vendors

Personal Attributes:

• Meets Gilero Core Values:
• Collaboration and Innovation of Excellence and Integrity
• Productive in a fast-paced, entrepreneurial environment.
• Commits to excellence and quality service to external and internal customers.
• Adheres to established policies and procedures, while contributing to continuous improvements.

Eligibility To Work:

• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Gilero does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work…