Sr. Process Engineer I

Auris Health

Auris Health

United States
Posted on Saturday, September 9, 2023
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Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.


I Am Abiomed | I Am Heart Recovery | Patients First!

The  Sr. Process Engineer I  will oversee the design, development, improvement and validation of manufacturing processes, tooling, and fixtures in order to meet manufacturability requirements for new and existing products. They will be responsible for ensuring the highest level of product quality, cost-effectiveness, and manufacturing efficiency.


Principle Duties & Responsibilities:

·       Develop, implement, and maintain efficient and effective manufacturing processes, systems and equipment.

·       Collaborate with cross-functional teams, including R&D, quality, and regulatory affairs to ensure product development and launch goals are met.

·       Analyze and improve production processes to reduce cycle time, reduce complexity, increase efficiency and yield and lower production costs.

·       Qualify and optimize processes and tooling via IQ,OQ,PQ, Gage R&R, process capability studies, and DOE’s.

·       Develop and maintain process documentation, including standard operating procedures, work instructions and training materials.

·       Participate in the investigation of non-conforming product (MRB) and implement action plans for internal corrective actions and audit findings.

·       Lead team problem solving using structured approaches likes: 8D, DMAIC, Fishbone Diagrams, 5Y, is/is not.

·       Lead, mentor and direct other more junior engineers in their short and long term tasks / projects.

·       Lead continuous improvement projects and support process improvement initiatives to drive product and process excellence.

·       Ensure production processes are in compliance with regulatory and quality standards, such as FDA, ISO and GMP.

·       Support the selection and qualification of suppliers and contractors to support production requirements.

·       10% international travel required.


Job Qualifications:

·       Bachelor's degree in Mechanical, Electrical, Industrial or Manufacturing Engineering, or a related field.

·       4 years of experience in a medical device or related manufacturing environment.

·       Strong knowledge of manufacturing processes and process improvement methodologies, including Lean Six Sigma.

·       Strong project management skills with the ability to lead cross-functional teams.

·       Excellent communication and interpersonal skills with the ability to work with individuals at all levels of the organization.

·       Ability to understand and apply statistical techniques (Minitab preferred) to improve processes.

·       Knowledge of regulatory requirements for medical device manufacturing, such as FDA, ISO and GMP

Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.