Smaller but fast growing Medical Device company in Carlsbad seeks a Senior Design Engineer to join its growing team (we are also looking for a more junior design engineer as well). This role will support a wide variety of NPI projects along with line extensions. Ideal candidates would come out of the Spinal, Orthopedic, or Dental Industry with background designing and testing high precision mechanical devices. Experience with Medical Device Design Control process is a must. Excellent benefits and a fun/collaborative team.
Job Summary:
This position is responsible for supporting the development of new products, product improvements and line extensions of existing products. This includes but is not limited to: CAD design of components and systems, support of design documentation, engineering testing/analysis for new and existing products, and support of ongoing production, marketing, quality assurance and regulatory affairs activities.
Essential Job Duties and Responsibilities:
Design parts and/or systems using 3D CAD software
Responsibility for risk management for products and processes
Contribute to the development of user needs and design inputs
Research, analyze, and create intellectual property
Provide engineering support for regulatory submissions
Provide engineering support for production and quality assurance
Design, document, approve, and conduct testing related to new product development and testing required in support of existing products
Creation and review of change orders for documents related to engineering (drawings, procedures, etc.)
Provide materials and support for clinical studies
Suggest and implement internal process improvements
Create graphics as needed for documentation.
Some project management including:
Coordination of core team activities
Responsibility for following design control processes
Create and maintain the design history file during new product development
Management of project timelines
Responsibility for overall project success
Supervise and mentor lower level Design Engineers and R&D staff
Education, Experience, Skills, & Abilities:
Engineering degree with a minimum of 4 years of relevant experience
Proven ability to effectively lead product development team members
Proven success in leading cross functional teams to develop and commercialize new products
Proven ability to drive projects and motivate team members
Demonstrated ability to design complex mechanical devices
Strong written and verbal communication skills required
Strong organization skills, attention to detail, precision, and accuracy required
Strong mathematical skills with a working knowledge of statistics and statistical analysis required
Previous experience with engineering design and testing required
Previous cGMP/ISO experience in the medical device industry desired
Previous experience in designing/maintaining cGMP/ISO-compliant Quality Systems desired
Working knowledge of Microsoft Office software including Microsoft Project desired
Solidworks 3D CAD experience desired
Experience with manufacturing processes including plastic injection molding, metal part fabrication, and coating processes desired
Familiar with the use of a variety of inspection measurement equipment desired