|Date Posted||April 17, 2019|
Our client provides full service medical device product development from concept through commercialization. They are a small group of hands-on engineers who work with our customers on complex design ideas, transforming them into viable devices. They are 100% medical and combine a passion for engineering with solid expertise to offer practical solutions in a wide range of clinical subspecialties.
This individual is part of the senior management team and manages software engineering for all aspects and phases of medical device development projects.
ESSENTIAL JOB FUNCTIONS*:
- Contribute to management team discussions and decisions on operational and strategic issues to ensure that the company’s goals are met.
- Identify business opportunities, meet with potential clients, generate proposals for software development.
- Communicate with clients as part of the overall program management process.
- Manage and grow a team of software engineers working on a variety of projects.
- Generate quality procedures relevant to software development to keep company's compliant with FDA requirements and the latest revision of ISO 62304.
- Contribute to the design and development of medical devices, systems, and standalone software from concept through market introduction and design for manufacturing.
- Produce prototype software for testing and evaluation by client companies.
- Prepare software documentation release packages. Prepare Document Change Orders (DCOs) to release documentation.
- Identify software development needs. Specify and purchase components, equipment, materials and supplies. Identify and interact with vendors.
- Generate job descriptions for software personnel, drive hiring for the software group. Supervise personnel.
- Contribute to product and software verification and validation testing to demonstrate product safety and efficacy including EMC/Electrical Safety (60601, 61010, etc.). Develop protocols, plan testing, and coordinate/perform testing. Write test reports which draw conclusions from the results.
- Ensure that all work satisfies the requirements of the company's Quality Manual, with particular emphasis on Design Control.
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES:
- Bachelor's degree in Electrical/Software Engineering. Other advanced degrees may be advantageous or considered.
- Minimum of 15 years of medical device product design and development experience is required.
- Demonstrated ability to bring products from concept to market.
- Ability to interact with client companies in a professional manner.
- Familiarity with FDA QSR and ISO 13485 medical device regulations.
- Familiarity with risk documentation and ISO 14971
- Familiarity with Usability considerations in design of medical products and IEC 62366
- Depth of knowledge in one or more clinical and product areas.
- Depth of knowledge in one or more technical areas, for programming and software life cycle controls.
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