Position Summary:Responsible for the design and development of innovative medical devices. The Engineer will contribute to cross-functional 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 high-quality 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
- 1+ years' experience in the medical device industry
- Medical design and development experience
- Experience launching medical devices
- Hands-on 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)
- Short-Term & Long-Term Disability Insurance (company paid)
- Subscription to Calm.com
- Employee Assistance Program
- An environment of belonging where everyone can thrive
