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 position for Staff or Principal R&D Engineer, based on experience, reporting to the VP of R&D. Starlight is seeking an experienced individual contributor with a proven track record for successfully developing and bringing to market Class II or III medical devices.

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 novel prototypes, developing manufacturing processes, developing testing and manufacturing plans, supporting regulatory submissions, and transferring designs to manufacturing.

KEY RESPONSIBILITIES

• Own the design and development of novel, complex, intervascular medical devices in the field of pediatric cardiology.

• Develop solutions to complex technical problems that require in-depth analysis of variable factors.

• Technical project leadership driving projects to completion in a fast-paced environment.

• Creates prototype designs using CAD, machining, rapid prototyping, and other fabrication techniques

• Design for manufacturing, including the design of fixtures, tooling and processes.

• Conduct and design feasibility studies to verify functionality of prototypes.

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

• Independent demonstration of engineering principles and applied skills. Ability to understand, analyze, and troubleshoot very complex systems.

• Work with latitude for independent action or decisions. Self-manages time, completes all tasks with minimal guidance.

• Influence design direction. Capable of leading business-critical technical projects. Can lead team of junior engineers and technicians.

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

• Able to develop a deep understanding of customer needs, clinical use cases, anatomy, and physiology and can translate clinical and customer needs into design requirements.

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

• Compliant utilization of design control process for Design and Development, including creation of quality records, leading of V&V planning and testing, and participation in design reviews.

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

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

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

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

• Assist with product troubleshooting on the assembly line.

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

BASIC QUALIFICATIONS

• BS degree in relevant field of engineering and 6+ years of medical device engineering experience in medical device development. Advanced degree may be considered toward experience.

• Comfortable working in a fast-paced start-up environment.

• Direct experience designing and developing intravascular medical devices through the Product Development Process. 

• Previous experience executing design and process validations.

• Experience with test method development, process development, and transfer to manufacturing.

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

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

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.