WHO ARE WE? Endotronix is a medical device company that aims to transform the treatment of heart failure, a chronic, progressive condition in which the heart is unable to pump enough blood to support the body. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure. These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs. With our recent PMA approval from the FDA, we are preparing to grow our team - it's a great time to join Endotronix! WHAT YOU'LL DO As a member of the Quality Team, the Quality Engineer will review and monitor risk analyses, design verification/validation protocols and reports. Ensure test methodologies are technically sound and sufficient given level of risk assessed. Support regulatory requirements by participating in design reviews. Encourage continuous improvement in all documented procedures to help streamline production.
- Develop a thorough understanding of the entire product lifecycle for Endotronix product
- Provide quality engineering input to establishment of product specifications, quality plans, and manufacturing procedures which consider risk management
- Review and approve design verification and validation protocols and reports to ensure that test article selection, sampling rationales and test methodologies are technically sound and sufficient given level of risk and internal/external requirements.
- Review risk analyses and design and usability FMEAs for adherence to requirements
- Participate in design reviews to ensure customer and regulatory requirements have been properly translated into design inputs which are complete, unambiguous and do not conflict.
- Encourage continuous improvement in design control activities and proactive utilization of quality tools with design team.
- Support design for manufacturing in the design phase through design transfer to manufacturing, both internally and externally
- Support manufacturing process optimization to encourage reproducible quality outcomes
- Assist with management and monitoring of process control metrics in manufacturing environment.
- Develop sampling plans for quality assurance based on product risk and supplier performance
- Perform root cause analysis of field, incoming, and manufacturing issues and implement corrective actions.
- Apply learned techniques and contribute to analysis and investigation to solve problems
- Support suppliers and internal investigations on quality related issues and returned material analyses.
- Model a culture of quality within the company and guide employees in best quality practices.
- Build and enhance productive internal and external working relationships to resolve mutual problems by collaborating on procedures or transactions.
WHAT YOU BRING TO THE TABLE REQUIRED:
- 5+ years' experience in quality engineering role and/or 3+ years' experience with an advanced degree
- Experience with quality principles and tools
- Capability in application of statistical techniques and sampling plans
- Skills in root cause analysis and determination of appropriate corrective action
- Working knowledge of IS013485 and IS014971 requirements
- Strong organizational skills
- Proven ability to work independently and in a collaborative team environment
DESIRED:
- Experience in both design and manufacturing environments
- Experience in medical device industry, preferably with electromechanical devices and medical device software
- ASQ Certified Quality Engineer
- Technical writing skills, experience creating SOPs in a Quality Management System
EDUCATION
- BS/MS in an engineering discipline
WHO YOU ARE
- Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customers
- Someone with a bias for action and quick iteration as opposed to perfection
- A quick learner, who is able to work independently, multitask, and drive your own projects
- An effective communicator and collaborator who can synthesize insights from multiple stakeholders across business functions to deliver purpose-built insights models and tools that provide easily interpretable and actionable results
- A team player who can inspire teams to deliver together, embodying the idea that the whole is greater than the sum of the parts
- Passionate about digital healthcare and leveraging Data to deliver innovative solutions at scale
WHAT WE'RE LIKE
- Willing to have the direct and honest conversation . Not afraid to confront the facts (or be confronted) and develop a plan to move forward.
- Competitive spirit and drive to win. Strong sense of initiative, internal motivation, and an unrelenting focus on results.
- Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.
- Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results.
- Entrepreneurial, flexible, yet results focused.
- High degree of intellectual curiosity, honesty, and capability.
- Low ego and humble in spirit in spite of your track record of outstanding performance.
LIFE AT ENDOTRONIX Endotronix. is an equal opportunity employer. We are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, sex, marital status, citizenship status, age, veteran status or disability. Furthermore, we do not tolerate any form of discrimination or harassment of our employees by co-workers, supervisors, customers, or vendors. This commitment extends to our policies on recruiting, advertising, hiring, placement, promotion, training, transfer, wages, benefits, termination and all other privileges, terms and conditions of employment. This policy applies not only to recruitment and hiring practices, but also includes affirmative action in the area of placement, promotion, transfer, rate of pay and termination. Executive, management and supervisory levels have the responsibility to further the implementation of this policy and ensure conformance by subordinates