Job Description
Job Description
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
This individual will develop current processes with the goal of scalability and with a focus in software for
manufacturing and test processes. Requires knowledge of software development process, requirements
definition, and software validation.
- Lead and support process development activities to increase throughput and ease of manufacture to support scalability.
- Design and develop LabVIEW custom software or similar for manufacturing and testing purposes.
- Develop and maintain software requirement documentation.
- Develop and maintain software validation plan and protocols.
- Lead and execute software validation testing for purposes of process validation.
- Coordinate projects.
- Work closely with internal and external customers and vendors to resolve issues and provide technical support
- Lead and direct meetings with other team members and hourly associates
- Manage manufacturing software within repositories.
- Provide training and guidance to other employee levels in the operation and testing of software.
- Develop and participate in process tracking metrics and use these to drive process improvements (Process capacity tracking, etc.)
- Interact with vendors and suppliers to ensure timely completion of deliverables.
- Perform additional related actions and duties as outlined and requested by management
WHAT YOU BRING TO THE TABLE
- Software Development or Software Test Engineer or similar with 5-7 years experience
- Experience with developing manufacturing or test software.
- Strong proficiency with LabVIEW and MATLAB.
- Experience with Python - preferable.
- Experience with developing software requirements and validation.
- Medical device software validation experience ISO13485 preferable
- Medical device manufacturing GMP quality experience preferable
- Experience with unit testing.
- Strong Project Management skills
- Demonstrated ability to work independently with minimal supervision.
- Excellent oral and written communication skills, particularly in technical writing and documentation.
- Demonstrated organizational, interpersonal, and critical thinking skills.
- Proficiency with Microsoft Office Suite.
EDUCATION
BS in Computer Science, Computer Engineering, Electrical Engineering or equivalent.
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