R & D Technician - Device Design
As a key member of our Development, Technology and Engineering team, the R&D Technician - Device Design will work as part of cross-functional Device Design project teams through all phases of the design development process, supporting the execution of project activities through product launch. Responsible for developing and testing solutions to solve technical problems. Assists engineers, inspects products, conducts tests, and collects data, designs and develops tools and processes, and develops design control documentation. Updates and/or edits existing documents in compliance with government regulations, industry standards and company requirements.
Duties and Responsibilities:
- Work with team to write and edit Design Control documentation
- Assist on technical issues, including design of equipment, packaging, tooling and related documentation (drawings, procedures, specs)
- Utilize CAD software to design and document prototypes, packaging designs and fixtures
- Assist project teams in establishing specifications and quality standards
- Prepare and performs tests, analyzes data and writes reports
- Maintains detailed documentation through all phases of development, testing and analysis
- Minimum two-year degree with 9+ years related experience or equivalent combination of education and technical work experience.
- Familiarity with regulatory requirements associated with Quality Systems for medical devices and Combination Products
- CAD experience is required
- Proficient with MS Office
- Research & Development Technician experience (preferably in medical device industry)
- FDA Design Control Documentation experience
- Experience writing technical reports and good engineering notebook documentation skills are required
- Broad engineering knowledge in new product introduction, cost reduction, and quality improvements
- Documentation skills for data collection, process instructions, Engineering Change Orders, test protocols and reports, etc.
- Root Cause/Problem Solving techniques
- Familiarity with basic fabrication processes, molded parts and related medical device materials
- Communication with outside suppliers for the specification and acquisition of materials
- Manage a varied workload
- “Can do” attitude and team player with strong interpersonal and team-building skills.
- Comfortable in a startup environment where process and role structure is frequently missing or changes rapidly.
- Demonstrated alignment with and ability to put Intarcia’s Core Values into operation: