Are you ready to lead product development for a promising medical device startup? Do you have experience with commercialization and regulatory approvals? If yes, please read on!
HistoSonics’ unique new platform technology has the potential to fundamentally change the nature of cancer therapy. Robotically Assisted Sonic Therapy (RAST)™ uses histotripsy and the mechanical properties of focused ultrasound to destroy targeted tissues without damaging surrounding tissue or structures. This non-invasive, non-thermal treatment can be used to safely, precisely and effectively destroy unwanted tissue throughout the body, reducing patient trauma and healthcare costs.
About the Role
The Electrical Engineer provides leadership and direction to the product development, quality assurance, and documentation efforts related to HistoSonics’ product development effort.
The key responsibilities range from research support and feasibility analysis to the development of new products while closely adhering to HistoSonics’ quality system and design controls.
- Assist with the setup of the HistoSonics system for ISO 60601 and emissions/immunity testing.
- Debug and resolve test failures with changes to the design.
- Develop product and user requirements, electrical design requirements, test procedures, and design output and verification and validation documentation for the product.
- Contribute to risk analysis and decision-making processes related to features, specifications, and characteristics of our products.
- Develop a project plan at the start of each project using appropriate planning and project management tools and within the company’s quality system guidelines; conducts routine project and design reviews and publishes meeting minutes.
- Coordinate the orderly release of new products to Manufacturing.
- Contribute to company’s IP portfolio by identifying and documenting trade secret and patentable inventions.
- Perform applicable responsibilities in compliance with the Company’s Quality Management System.
- Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to team members in an open, balanced and objective manner.
- Maintain knowledge of current and emerging trends in the industry.
- Manage third party vendors to ensure deliverables are meeting HistoSonics’ product and timeline requirements.
Qualifications and Skills
- Experience in medical device industry, including success with regulatory approval and in commercializing products
- Experience resolving ISO 60601 failures
- Ability to participate in high-level technological discussions and convey complex ideas to less technically knowledgeable parties (written and verbal)
- Ability to prioritize multiple tasks and deadlines, and possess excellent follow through skills.
- Record of converting strategic plans to product, development, and/or operational objectives
- Strong analytical, critical thinking, and problem-solving skills with attention to detail
- Bachelor's degree (BS, BA) in electrical engineering or equivalent
- Experience in product development within a healthcare environment
- Ability to travel by car or air (day trips and overnight stays) up to 30% of the time.
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Role: Electrical Engineer (Medical Device) - HistoSonics, Inc
Location: Ann Arbor,
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