RD Engineer
RD Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
About Scientia Vascular:
Our mission is to save lives. Scientia Vascular is a leading innovator and manufacturer of endovascular medical devices. We use micromachining and microfabrication processes to manufacture products that provide physicians with enhanced performance for optimal outcomes for their patients.
Position Summary:
Responsible for the design and development of innovative medical devices. The Engineer will contribute to crossfunctional development teams through product design research investigations verification and validation testing process development and preparation of specifications and design control documentation. This position will work under general direction and have latitude in determining how to solve problems.
Primary Responsibilities:
- Responsible for medical design and development including new products as well as product changes/enhancements.
- Fully participates in and successfully contributes to project teams typically including the following activities: product design and development test and selection of materials research investigations (animal and bench studies) preparation of specifications process development and capability studies design verification and report preparation and design control documentation.
- Works independently to plan and schedule own activities necessary to meet timelines.
- Contributes to intellectual property position of company by inventing concepts and designs for new products/processes and submitting idea disclosures.
- Creates prototypes from design concepts. Turns concepts into fully functional products.
- Performs troubleshooting on new products/process problems as related to design material or process.
- Designs and coordinates standard engineering tests and experiments.
- Designs procures and fabricates tooling and fixtures.
- Completes verification and validation testing including animal studies as needed.
- Prepares accurate and thorough test reports/documentation to communicate results to technical community and support regulatory submissions.
- Comply with applicable FDA and international regulatory laws and standards
- Maintains a comprehensive and accurate laboratory notebook document concepts designs drawings and processes.
- May train and/or provide work direction to technicians.
- Works cooperatively with process development quality manufacturing regulatory clinical and marketing to ensure project success.
- Contributes to the creation of highquality design control deliverables.
- Provides engineering and technical support of products in the field which will include travel to cases.
- Provide support in the resolution of product complaints and/or product issues.
- Other duties as assigned with or without accommodation.
Requirements:
- BS in Engineering
- 15 years experience in the medical device industry.
- Medical design and development experience
- Experience launching medical devices
- Handson ability to make medical device prototypes.
- Experience with medical device design controls
- Test method development
- Statistical analysis of various types of data
- 3D modeling (SolidWorks)
- Strong written and oral communication skills.
- Proficient with Microsoft Excel and Word.
Key benefits we provide:
- Medical Dental Vision insurance
- Generous Paid Time Off (PTO)
- Paid Parental Leave
- Paid Holidays
- 401k Plan (with a generous employer match)
- Life Insurance (company paid)
- ShortTerm & LongTerm Disability Insurance (company paid)
- Subscription to Calm
- Employee Assistance Program
- An environment of belonging where everyone can thrive
Commitment to Equal Opportunity:
The Scientia Vascular culture is centered on the principals of equal opportunity for all employees. Consistent with our culture all qualified applicants will receive consideration for employment without regard to race color religion gender gender identity or expression family status marital status sexual orientation national origin genetics disability age or veteran status or any other nonmerit based or legally protected grounds.
Visit our website and learn more about us atwww.scientiavascular.
Employment Type
Full Time
