Senior R&D Engineer/Solidworks
- Hands on senior mechanical engineer to oversee design and development activities from concept to commercialization, for advanced diagnostic instruments.
- Adheres to project timeline, ability to identify resource constraints and requirements.
- Independent, manager able to multi-task in a timely manner. Supervise and provide direction to the technicians and junior engineers with the ability to utilize external resources to meet the goals. * Oversees o Product documentation o Test protocols and performance and reliability tests o Design history files
- Perform design failure analysis, competitive product analysis and participate in invention discloser.
- Ensure all development activities comply with IS0, QSR and company?s standard operating procedures.
Requirments:
- Must have 8+ years successful design and product development experience in medical device industry. Experience in project management is plus.
- Ablity to work closely with Quality/regulatory and Manufacturing, to archive FDA approval transfer into manufacture
- Prerequisite of at least a BS mechanical or Plastics engineering
- Proficiency in Solidworks a must,and experienced in designing both metal and plastic/injection mold components
- Knowledge of injection molding, polymers and catheter manufacturing processes
- Knowledge of FDA and ISO regulations
About Avantis Medical Systems:
Located in Sunnyvale, we are pre-privately held, Medical System Device Company that has great entrepreneurial environment. With an experienced management team that has a successful track record of taking several products to major market.
We are seeking talented individuals to join our dynamic team. Employees will receive a competitive compensation package.
Please forward your resume to: snipped-for-privacy@avantismedical.com
An Equal Employment Opportunity and Affirmative Action Employer
Avantis Medical Systems, Inc snipped-for-privacy@avantismedical.com (408)733-1847