DESCRIPTION

This is an exciting opportunity to work for a small, friendly, fast-paced start-up medical device company with a motivating mission to help babies born with congenital heart disease by developing best-in-class devices. The company is headquartered in San Diego, CA and maintains a network of advisors, active board members, academic, and industry partnerships in support of device development.

This role is an on-site, full-time, paid R&D Engineer, reporting to the VP of R&D. Starlight is seeking a highly motivated individual contributor who is eager to work in a small, fast-paced startup environment.

The ideal candidate will be an independent self-starter that collaborates well within a small team. The responsibilities include assisting with the design and development of several novel pediatric cardiovascular products, creating prototypes, developing manufacturing processes, developing and performing test plans, supporting regulatory submissions, and transferring designs to manufacturing.

KEY RESPONSIBILITIES

• Work in a team environment to develop novel device designs in the field of pediatric cardiology.

• Create prototype designs using CAD, simple machining, rapid prototyping, and other fabrication techniques.

• Design fixtures and other manufacturing and fabrication tools.

• Prepare design documentation including drawings, models, specifications, and release documents.

• Conduct design feasibility studies to verify functionality of prototypes.

• Define and coordinate product testing (clinical and bench). Design and draft testing protocols, and create reports with summarizing and analyzing data and results.

• Design and conduct experiments in the lab to aid in design development and test method development, performing statically driven data analysis

• Participate in Verification & Validation test activities to ensure that products comply with technical specifications and user requirements. Generate test protocols and document test results.

• Participate in product development teams throughout the research and development process.

• Prepare and present periodic project performance updates to internal management.

• Understand, embrace, and ensure compliance to relevant Quality Systems and applicable government and industry regulations.

• Work with R&D scientists, engineers, managers and technical experts to develop, and implement design history file documents in the standard formats.

• Act as the technical contact with outside suppliers for custom components.

• Able to analyze results, solve complex problems, distill key findings, and translate into conclusions.

• Assist with information for product manuals, marketing specifications, literature, etc.

• Assist with product troubleshooting on the assembly line.

• Assist in continual improvement of quality system and documentation.

• Complete regular literature searches and share associated information with team.

BASIC QUALIFICATIONS

• BS degree and 2-4 years of mechanical engineering experience, or MS degree in relevant engineering field (Mechanical, Biomedical, Bioengineering, etc.) and 1-3 years of medical device R&D engineering experience.

• Knowledge and/or experience in medical device product development a plus (medical devices, therapy types, materials used, manufacturing process, simulated use testing. etc.)

• Product development or manufacturing experience is a plus.

• Ability to read and understand regulatory standards, engineering drawings, clinical literature, and sources of technical and regulatory information.

• The position requires excellent organizational and communication skills and a proven track record managing significant portions of projects independently on time and on budget.

• Must have experience in development processes and documentation writing.

• Experience or familiarity with Root Cause Analysis and/or CAPA is a plus.

• Experience with CAD modeling in SolidWorks.

Job Type: Full-Time

Expected Hours: 40 per week

Pay: Salaried

Work Location: In person, San Diego, CA

Contact: RnDjobs@starlightcardio.com

Starlight Cardiovascular is an equal opportunity employer. We strive to create a diverse and inclusive environment for all employees. We benefit from having a workforce that is representative of the patients and families we serve.