Manufacturing Engineer I

A medical device firm called Endotronix wants to revolutionize the way heart failure is treated. Heart failure is a progressive, chronic illness where the heart cannot pump enough blood to sustain the body. Proactive management tools for best practice therapy and the identification of worsening heart failure are part of our Cordella Heart Failure System (CHFS). These user-friendly resources lower hospital admission rates and enhance patient quality of life, which lowers medical expenses. Now is a fantastic time to join Endotronix as we are ready to expand our staff following our recent FDA PMA approval!

WHAT YOU WILL DO

The main duties of this Manufacturing Engineer I include creating and managing the Cordelia System and Cordella Pulmonary Artery Sensor System (Cor PASS) manufacturing process. You'll :

• Support process development operations to consider design modifications, performance and yield enhancements, and / or product mitigations.
• Create, write, evaluate, and carry out production documentation (manufacturing process instructions, inspections, specification / drawings, routers, etc.) to support in-house product manufacturing.
• Participate in NCR resolutions, CAPA investigations, and other investigative tasks.
• Collect, arrange, and evaluate data.
• Educate staff on production processes.
• Create and keep up-to-date risk paperwork (PMEA, etc.) for the product and manufacturing process.
• Execute and assist with all facets of Process Validation as well as Design Transfer efforts to manufacture.
• Purchase and inspect capital equipment; troubleshoot equipment with your hands.
• Create and take part in process tracking metrics, such as cost tracking, scrap / yield tracking, etc., and use them to motivate process changes.
• Create and carry out IQ / OQ / PQ process validations for manufacturing processes and equipment.
• Create, design, and build test fixtures for manufacturing and inspection.
• Utilize Test Method and Gage R&R analysis as part of the validation of inspections.
• Communicate with suppliers and providers to guarantee that deliverables are completed on time.
• Carry out extra relevant tasks as directed and asked by management.

ACCESSORIES FOR THE TABLE

Preferably, you have 0–3 years of medical device engineering experience, working familiarity with FDA and ISO regulations and standards, and a proven capacity to operate autonomously with little guidance. Additional qualifications include :

Learning

A bachelor's degree in computer engineering, mechanical engineering, biomedical engineering, electrical engineering, or a related field.

WHO YOU ARE

You are :

OUR NATURE

We value :

ENDOTRONIX LIFE

An equal opportunity employer is Endotronix. Regardless of race, creed, color, religion, national origin, sex, marital status, citizenship status, age, veteran status, or disability, we are dedicated to giving everyone equitable job opportunities.

Additionally, we do not accept any kind of harassment or discrimination against our employees by coworkers, managers, clients, or suppliers. Recruiting, advertising, hiring, placement, promotion, training, transfer, pay, benefits, termination, and any other benefits, terms, and circumstances of employment are all covered by this agreement.

This policy covers affirmative action in the areas of placement, promotion, transfer, rate of pay, and termination in addition to recruitment and hiring procedures.

It is the duty of the executive, managerial, and supervisory levels to advance the application of this policy and guarantee compliance by subordinates.

People are advised to speak with their supervisor, another manager, or a human resources representative if they believe they are the victim of prejudice. We will not accept retaliation against claims.

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