Responsible for the design and development of electromechanical medical devices. Work is expected to encompass both the development of new products and maintenance of existing products. Position will lead large scope projects, multiple projects, or projects of significant strategic importance to the business.
Principal Duties and Responsibilities
- Leads the development of new products and manufacturing processes. Identifies all tasks required to complete project assignments according to Design Control procedures. Recommends project budget and schedule to carry out programs on a timely basis.
- Designs or directs design work for manufacturability, inspectability and optimum cost
- Conducts or participates in root cause analysis for problem solving
- Contributes to generation of a comprehensive protocol for testing/analyzing the product
- Coordinate product evaluation with surgeons and other HCPs
- Prepares definitive new product specifications or modifies existing specifications
- Generates or updates design assurance documentation for the product
- Generates and/or manages the creation of prototype models to evaluate new design concepts
Expected Areas of Competence
- Electromechanical medical device development
- Working knowledge of IEC60601-1
- Working knowledge of IEC60601-1-2
- Working knowledge of ISO14971
- Working knowledge of IEC62304
- Working knowledge of IEC62353
- Working knowledge of IEC60529
- Ability to troubleshoot electrical circuits for root cause analysis
- Lithium-ion battery development for medical devices
- Experience working with embedded software
- Experience writing system, hardware and software specifications for 510(k) devices
- Full working knowledge of and significant level of experience with new product development including project management of multiple complex projects
- Demonstrated ability to methodically investigate, determine appropriate solution and resolve significantly complex problems using current and new technologies. Ability to develop or identify new technologies to address problems.
- Ability to process customer complaints, engineering changes and nonconforming product, and make recommendations based upon business principles
- Professional, concise, tactful and sensitive in communications. Accomplishes objectives when communicating with internal personnel, and external customers and vendors. Able to diplomatically negotiate with a requester concerning design, process, scope or timetable. Strong ability to represent the department and company.
- Demonstrated good written and verbal communication skills including presentation skills.
Preferred Areas of Experience Includes:
- Designing embedded circuits for medical device applications.
- Working knowledge of Altium or equivalent circuit board design software.
- Designing battery management systems and battery chargers for lithium-ion applications.
- Designing/specifying switching power supplies.
- Electromagnetic compatibility compliance.
- Designing electronics for motor control applications.
- Minimum B.S. degree from an ABET accredited school (or global equivalent) in one of the following engineering disciplines with 5-7 years of experience: Electrical Engineering, Electrical Engineering Technology, or Software Engineering.
- Medical device experience preferred.
- Up to 10%