Senior Product Development / R&D Cardiac Leads Engineer

Job Posting  -  SENIORPRODUCT DEVELOPMENT / R&D ENGINEER, MEDICAL DEVICES, CARDIAC LEADS 

Company Background

 

Surgi-Vision Inc. is the recognized leader in developing fullclinical solutions for Magnetic Resonance Imaging (MRI) guided minimallyinvasive surgical procedures. We are a well funded, growth stage company withproven technologies and a substantial portfolio of intellectual property. Ourtechnologies have the potential to revolutionize the way surgical proceduresare done today, improving outcomes, healthcare economics and patient’s lives.

 

Weare building a team of the most talented people in the medical device industry.If you are confident in your abilities, the best in your field and you enjoydeveloping and commercializing revolutionary medical devices / procedures,Surgi-Vision might be place for you.

 

We are currently seeking a Senior Product Development /R&D Cardiac Leads Engineer at our Southern California or Baltimore location. Qualified candidates areencouraged to submit a resume for this exceptional opportunity.

PositionSummary

This position requires a results-oriented, experienced, hands-on, medicaldevice product development engineer to work with a team to develop arevolutionary Cardiac Pacemaker / Implantable Cardioverter Defibrillator (ICD)Lead.  Candidates must be comfortable workingin a small, customer focused, entrepreneurial environment with a highlymotivated team and limited infrastructure.

ResponsibilitiesDesign and development activities required forthe commercialization of a Cardiac Lead. Work with others to determine specific user requirements and design inputs.Identify and apply applicable industry standards / specifications.Apply sound and creative engineering problem solving techniques. Maintain accurate records throughout the development process.Develop engineering drawings and specifications.Develop and write test methods, protocols and reports. Project execution and documentation per established design control procedures. Assist in Risk / Hazard Analysis including Failure Mode and Effect Analysis (FMEA).Participate in design verification and validation efforts to insure design inputs and user requirements are met. Design for manufacturability.Participate in design reviews.Assist in regulatory filings / submissions.Assist in design transfer to full production.Assist in developing and participate in user validation studies.

 

Qualifications

 BS or higher in Mechanical Engineering or related field.4+ years of successful experience within the medical device industry. Understanding of FDA Quality System Regulations (QSR), European Community Medical Device Directives (MDD) and EN 13485.Ability to thrive in a fast paced, multidisciplinary environment. Excellent communication (written and oral), presentation, and technical writing skillsA demonstrated history of solving problems through analytical reasoning and creative solutions.Extensive knowledge and experience with Cardiac Leads, development and manufacturing.Ability to travel.

 

Salary

 

Since we are seeking the best, this position will enjoy anexcellent salary and equity in the form of stock options

 

Benefits

 Medical, Dental and Vision Insurance Company paid Life, AD&D and LTD Insurance Flexible Spending Accounts 401K Paid Holidays and Vacations

 

 

Qualified Candidatesplease forward your resume to:

  careers@surgivisioninc.com

Notice to Recruiters and StaffingAgencies

Surgi-Vision requires that all recruiters and staffing agencies have asigned contract on file with Surgi-Vision. Any resumes submitted by recruitersor staffing agencies without a signed agreement in place will be consideredunsolicited and Surgi-Vision will not be obligated to pay a referral fee.