Manufacturing Engineering Manager

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

The Manufacturing Engineering Manager will be responsible for leading direct and/or indirect reporting individuals on team-based and/or project-based activities. Primary activities will focus on process development, process control and process validation.

• Lead direct and/or indirect reporting individuals on team-based or project-based activities and goals.
• Lead and support process development activities to account for design changes, performance and yield improvements and/or mitigations to the product.
• Lead and support in-house manufacturing of product through the development, authoring, review, and execution of production documentation (manufacturing process instructions, inspections, specification/drawings, routers, etc.).
• Lead and/or participate in CAPA investigations, NCR resolutions, and other investigation activities.
• Gather, organize, and analyze data.
• Train personnel on production procedures.
• Author and maintain risk documentation (PFMEA, etc.) for the manufacturing process and product.
• Perform and support Design Transfer activities to manufacturing, including all aspects of Process Validation.
• Acquire and validate capital equipment. Perform hands‑on equipment troubleshooting.
• Develop and participate in process tracking metrics and use these to drive process improvements (Scrap/Yield Tracking, Cost Tracking, etc.)
• Write and Execute Process Validation of Equipment and Manufacturing Processes in the forms of IQ/OQ/PQ.
• Design, develop and fabricate test fixtures for the purposes of manufacture and inspection.
• Perform Test Method Validation of inspections including Gage R&R analysis.
• Interact with vendors and suppliers to ensure timely completion of deliverables.
• Perform all other actions and duties as outlined and requested by management.

WHAT YOU BRING TO THE TABLE

• 3-5 years medical device engineering experience preferred.
• Working knowledge of ISO and FDA guidelines and requirements
• 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.
• Strong background in mechanical or electrical design.
• Experience with statistical data analysis.
• Experience with Solid Works, Minitab, Labview, MATLAB preferred.
• Proficiency with Microsoft Office Suite.
• Risk analysis experience (PFMEA, DFMEA, etc.)

EDUCATION

• BS in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Computer 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 collatorator 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…