As a leader, manage the quality engineering functions of development projects within a multidisciplinary project team. This position is newly created as the number of projects has increased.
· Intervention radiology support
· Attacking different kinds of clot
· Leading market in product performance by stroke devices
· Lighting 12 & 8 pulling more clots than ever before (COVID positive patients, minimizing risk of death). Just released 2 weeks ago!
Provide subject matter expertise with external/internal audits, design of experiments, process validations, statistics, test method validations, measurement system analysis, sterilization validations, new product development, and risk.
· Deep understanding of sterilization and biocompatibility
· Working knowledge of data collection, data analysis/evaluation, and scientific methodology
· Class III (preferred) or II medical device experience. Catheter experience helpful
· Previous manufacturing engineering or process development experience preferred
· 4-5 direct reports with ranging levels
· 5 years of highly regulated experience, 3-5 of that as a manager
· Open to med device/ biotech (patient injury)
· NPI, design transfer to manufacturing
· Manage & support product throughout life cycle, all the way to test method validations to tech transfer (NPI/NPD) and sustain/continuous improvements.
· Background in sterilization/biocmpatbility would be ideal, management is more important.
· - In design control and does NOT just push papers
· - Active participants on product life cycle in technical level
· - Better product quality because they are leading ROOT CAUSE
· - "Advanced quality engineering" from larger companies
Whats in it for you?
· A collaborative teamwork environment where learning is constant and performance is rewarded.
· The opportunity to be at the forefront of technology that is revolutionizing the treatment of some of the world's most devastating diseases.
· A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.
Why Work Here?
Rapidly growing, cutting edge medical device company.