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 The Production Engineer 1 will work with all production lines, and be responsible for helping with process efficiency, process scaling and quality improvement. The Production Engineer 1 will also collaborate with Quality, Manufacturing, and R&D as appropriate for non-conforming material investigation, disposition, and documentation. The Production Engineer 1 will also assist with ensuring appropriate inventory of finished goods, including the review of respective quality records generated from manufacturing. Work with Manufacturing Engineering and Production Manager to assess and analyze current production methods and identify areas of improvement. Collaborate with Manufacturing Engineering and Production Manager to analyze process efficiency, including completing time studies. Assist with updating manufacturing procedures, inspection procedures, forms, and checklists. Create and review process documentation to support changes and improvements in the production process. Create and review document change requests to support on-going process/documentation changes. Review quality records generated for the production lines. Support the control, investigation, disposition, and documentation of non-conforming material, collaborating with Quality, Manufacturing and R&D where appropriate. Collaborate with Production Manager, Quality and Operation to ensure appropriate inventory of finished goods. Collaborate with Production Manager and Manufacturing Engineering for capacity scaling, and quality improvement activities to meet business needs. Perform execution of material control procedures including receipt, identification, quarantine and material movement include use and maintenance of material control, non-conformances, work order and serial number logs and databases. Maintain knowledge of all procedures, relevant specifications and applicable regulations and standards related to areas of responsibility. WHAT YOU BRING TO THE TABLE 0-1 years of related experience in Engineering or Manufacturing/Operations Excellent technical writing and communication skills. Excellent analytical, problem-solving, and critical thinking skills. Great attention to detail and organizational skills. Demonstrated ability to work independently with minimal supervision. EDUCATION BS in an engineering discipline, biomedical engineering or industrial engineering preferred. 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 Individuals who feel they are the target of discrimination are encouraged to discuss the matter with their supervisor, another member of management or someone in the Human Resources Department. Retaliation against claimants will not be tolerated.
Job Title
Production Engineer I