Senior Mechanical Design Engineer
MicroAire Surgical Instruments
Are you an experienced engineer in the development of engineering concepts into viable electro-mechanical products? If yes, this could be the right position for you.
About MicroAire Surgical Instruments:
MicroAire is a leading designer, manufacturer and distributor of powered surgical instruments, Customer Centric and driven for success, MicroAire is a team dedicated to enhancing quality of life: for surgery for life.
MicroAire is located in beautiful Charlottesville Va. Home of University of Virginia and two large hospitals, Charlottesville is consistently ranked as one of the best places to live in America. We offer an excellent benefits package and compensation commensurate with experience. For more information www.microaire.com (EOE)
- Participates in assigned project teams to design components and assemblies with consideration for safety, reliability, manufacturability, usability and aesthetics.
- Works individually or within a project team. May lead a project team with minimal supervision.
- Works closely with Marketing and Users in the development of initial design inputs resulting in specific and measurable design requirements.
- Develops detailed specifications for components and assemblies, in the form of 3D models, CAD drawings, Bills of Material, and other written documents in compliance with company guidelines, procedures and applicable design control regulations (FDA CFR Title 21 part 820.30 – Design Controls).
- Develops and tests prototypes to design specifications. Develops testing requirements and writes test protocols for final Design Verification.
- Performs Verification testing as required for design verification and writes reports for Design Verification closure.
- Performs product and component risk analysis per ISO 14971 to ensure adequate mitigation of any risk identified.
- Assists Quality Assurance in developing inspection methods and acceptance criteria for new products.
- Assists in the development of techniques and equipment for the manufacture of new products.
- Exercises judgment on tolerancing, material selection, manufacturing methods, and component selection.
- Provides support to outside vendors to resolve technical issues.
- Provides support to outside sales force and customers to resolve technical issues.
- Provides test reports, drawings, and other requirements to Regulatory Affairs necessary for preparing regulatory notifications and submissions [510(k)s / PMAs / technical files] for domestic and international approvals as required.
Experience and Qualifications
- A bachelor’s or master’s degree in Mechanical or Biomedical Engineering.
- Five plus years of total design experience
- Three plus years involved in product verification testing.
- Proficiency in 2D drafting and 3D Modeling preferably SolidWorks
- Knowledge of ANSI Y 14.5 drafting standards
- GD&T and tolerance stack up analysis
- Thorough understanding of the design of mechanical components and assemblies
- Excellent technical and analytical skills.
- Excellent verbal and written communication skills.
- Excellent interpersonal, time management, and organization skills.
- Ability to apply basic scientific reasoning to resolve technical problems.
- Self-starter with the ability to work alone and in multiple team environments.
- Comprehensive medical device design skills
- Understanding of required regulations for medical device design control and manufacturing.
- Understanding of various surgical techniques as related to surgical instruments.
- Thorough knowledge of factors that affect the life of re-usable surgical instruments, such as corrosion, wear, fatigue and thermal cycling.
- Understanding of external standards and their integration into design requirements and testing
- Aligning design requirements with FDA guidance documents
- Experience with design and verification and validation of orthopedic surgical instruments
- Design Controls, Human Factors and Risk Management Training through AAMI
- Three years of experience in the medical device industry
- Experience designing electromechanical devices with high speed mechanisms
- Experience converting rotating motion into linear motion
- Experience with heat transfer and vibration analysis
- Experience with finite element analysis using 3D CAD files
- Understanding of Process and Instrumentation Diagrams with an ability to generate them
- Certified Solidworks Associate/Professional
- Knowledge of statistical techniques related to sample size calculation and data analysis
- Experience designing parts for plastic injection molding
- Greenlight Guru