Senior Development Engineer bei HistoSonics
HistoSonics · Plymouth, Vereinigte Staaten Von Amerika · Onsite
- Senior
- Optionales Büro in Plymouth
HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.
Location: Plymouth, MN (Onsite)
Position Summary:
The Senior Development Engineer will work within the Prostate team in support of HistoSonics’ product development effort. The key responsibilities of the Senior/Development Engineer range from research support and feasibility analysis to the development of new products while closely adhering to HistoSonics’ quality system and design controls. The Senior/Development Engineer will also play a key role in supporting HistoSonics’ clinical trials and certification efforts.
Key Responsibilities:
- Develops the product and user requirements, test procedures, and design output and verification and validation documentation for the product.
- Contributes to risk analysis and decision-making processes related to features, specifications, and characteristics of our products.
- Participate in the engineering for manufacturability and transfer to manufacturing (e.g. assessment of molds/tools required, manufacturing equipment definition/debug/validation, process definition/debug/validation, engineering builds, and product verification testing.
- Maintains a positive, results-oriented work environment, building partnerships and modeling teamwork, communicating to team members in an open, balanced, and objective manner.
- Creates / maintains a clean, safe, and effective work environment.
- Manages third party vendors to ensure that the vendor's deliverables are meeting HistoSonics’ product and timeline requirements.
- Ensures that design documentation is in accordance with Histosonics’ design control system (or external partner’s systems) and that all project deliverables are met.
Position Qualifications and Skills:
- Excellent written and verbal communication skills; comfortable with participating in high-level technological discussions; ability to discuss complex technology in clear, discernible terms with less technically knowledgeable parties as well as presentation skills are required along with top level interpersonal and facilitation skills.
- Demonstrated ability to develop and maintain relationships, internally and externally.
- Demonstrated ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills. Highly motivated, efficient, and enterprising with an inherent ability to drive tasks and projects to full completion.
- Strong analytical, critical thinking, and problem-solving skills with an attention to detail and organizational goals.
- 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)
- Experience working with quality management systems.
- A bachelor’s degree (BS, BA) in engineering or equivalent required plus 5+ years related industrial work experience.
- Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 25% of the time.
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.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
