Join us! We are looking for individuals who share our values and commitment to improving the treatment of peripheral artery disease and critical limb ischemia.
To apply for any of our current openings, please submit your resume to firstname.lastname@example.orgDesign, Develop and test peripheral endovascular products that are in compliance with all applicable quality and regulatory requirements such as the Quality System Regulation (21 CFR Part 820, ISO13485), Risk Management (ISO14971)
- Management of full life cycle development of catheter-based peripheral vascular therapy from conceptualization, design, prototyping, testing, clinical evaluation, design verification, validation, management of key suppliers, and commercial market launch.
- Assessing clinical needs via physician interactions, developing design inputs and outputs, and developing iterations to meet customer requirements.
- Project management and oversight of product development programs, include maintaining master project schedules.
- Create solid models/drawings using 3D CAD software and manufacturing prototypes
- Support pre-clinical laboratory testing and animal studies including protocol development and generating final reports.
- Work closely with suppliers to ensure products are manufacturable at the highest levels of quality and at reasonable cost
- Support Risk Management activities throughout the product life cycle. Makes deductions from varying facts or circumstances to make the determination regarding the acceptability of risks and utilize appropriate tools in the process (e.g. FMEA, Fault Tree analysis etc.).
- Analyze and evaluate product defects and perform failure investigations to determine root cause, failure modes, and implement corrective and preventive actions and/or recommend modifications that lead to product and/or process enhancements.
The above statements are intended to describe the general level of work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities
Job Requirements (The minimum qualifications required to adequately perform the job.)
Education and Experience
- 2+ years of experience in Medical Device Product Development, manufacturing and distribution with knowledge of Quality Systems, Quality Assurance, or Regulatory Compliance.
- Experience ensuring FDA, GMP, and ISO compliance involving Design Control and maintenance of Design History Files (DHF).
- Hands-on team player with the ability to work in a fast paced, dynamic start-up environment.
- Experience working with small cross-function product/process development teams
- Able to generate and communicate project strategies and scenario plans to team members, management, board members, etc.
- Knowledge and experience appropriate to perform/support risk management tasks. These shall include, where appropriate, knowledge and experience of the particular medical device (or similar medical devices) and its use, the technologies involved or risk management techniques.
- General office environment
- Laboratory environment
- Domestic and international travel
- Medical device research and manufacturing environment
- Includes varying work schedule
- Prolonged periods of sitting, standing and walking
- Travel by automobile, train and aircraft
- Occasional travel on weekends