Director of Engineering (Medical Device)

The Opportunity

This is an opportunity to serve as the Director of R&D at a well-funded medical device company developing treatments for cardiovascular disease. We are looking for someone to lead our San Clemente based team of engineers in the development of new stenting technologies, from concept through commercialization. This is an opportunity with a lot of growth potential.

Potential Responsibilities

Your responsibilities can range from: 

• Leadership
• Lead and mentor a team of engineers in the development of new and current concepts, from initial design through clinical validation.
• Collaboration
• Work closely with the drug formulation, clinical affairs, regulatory, and manufacturing teams to ensure success of the programs.
• Interact with various KOLs to gather device feedback and input.
• Planning and Execution
• Establish, implement, and report on the R&D department’s progress towards milestones and objectives.
• Own all design control activities (documentation & technical requirements) for verification and validation of developed products.
• Manage and coordinate internal and external resources to achieve our goals.
• Manage feasibility studies of designs to determine if technologies are capable of functioning as intended.
• Organize the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Support ongoing and future clinical trials from a technical perspective.
• Compliance
• Ensure that business affairs are conducted according to established corporate policy.
• Support and require compliance to the Quality Policy, Plan and Procedures.

Qualifications:

• Technical Skills
• Strong skills in design control
• Strong skills in catheter (delivery systems and balloon) and stent development
• Proficiency in 3D modeling (preferably Solidworks)
• Education
• Bachelor’s or Graduate degree in a technical field (preferably an engineering field)
• Experience
• 10 years of experience in medical device engineering
• 3 years experience in general team management
• Demonstrated track record of product development
• Knowledge
• Knowledge of FDA and ISO guidelines
• Knowledge of medical device industry trends and practices
• Soft Skills
• Excellent communication, team development, and problem solving skills
• Physical Demands
• Include having to frequently stand, sit, walk, climb stairs, lift up to 25 pounds, operate a computer, and/or travel by air/rail/auto.

Who is 17 Mission: 

We are a recruiting firm focused on helping talented individuals connect with mission-oriented companies that have significant funding and are working on pressing problems.