Sr. Research Engineer (Biomedical)
HistoSonics, Inc. · Ann Arbor, MI · 1 wk ago
On-siteEngineeringFull-time
Key Responsibilities
- Works closely with the R&D management team (Head of Research and Product Development) and the cross-functional team to translate clinical needs into engineering requirements.
- Manage programs or facets of programs/projects as required.
- Work as a member of the R&D team to plan, set up, carry out, and document scientific experiments related to acoustic, electric, robotic, and software system subcomponents.
- Develop models or computer simulations of human biobehavioral systems to obtain data for measuring or controlling life processes.
- Communicate with suppliers regarding the design or specifications of bioproduction equipment, instrumentation, or materials.
- Develop methodologies for transferring procedures or biological processes from laboratories to commercial-scale manufacturing production.
- Create, develop and/or execute relevant preclinical models supporting proof of concept, premarket and/or post-market evidence.
- Participate in preclinical and/or clinical research studies.
- Participate in developing requirements, test procedures, and design output documentation for HistoSonics products.
- Document, manage and collaborate on related intellectual property matters including new patent disclosures, applications and support during prosecution process.
- Contribute to risk analysis and decision-making processes related to features, specifications, and characteristics of our products.
- Maintain a positive, results-oriented work environment, building partnerships and modeling teamwork, and communicating to team members in an open, balanced, and objective manner.
- Perform applicable responsibilities in compliance with the Company's Quality Management System.
- Ensure that design documentation is in accordance with HistoSonics' design control system.
Qualifications And Skills
- Bachelor’s degree in biomedical engineering, biotechnology, or physics; advanced degree (Master’s or PhD) preferred in biomedical engineering, biotechnology, or physics.
- 5+ years of industry experience in modeling and simulating biobehavioral systems, advancing material research for product applications, and optimizing acoustic (ultrasound) system design; 3+ years of commercial experience preferred with advanced degree.
- Experience in complex systems design, engineering and product development (including product support during commercialization).
- Experience driving products through verification and validation, resulting in successful regulatory submissions (globally).
- Excellent communication skills and quality management systems experiences.
Benefits
We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.