Sr. Production Engineer I

Abiomed, part of Johnson & Johnson MedTech is recruiting for a Senior Production Engineer in our Sensor Operations group, located in Woburn, MA.

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.

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible.

For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

Patients First | Innovation | Winning Culture | Heart Recovery

Work with a highly skilled team in the micro assembly of Fiber Optic Pressure Sensors.

Duties and Responsibilities:

Sustain and Scale Production

• Control manufacturing processes while reducing defects and enhancing productivity and product quality

• Drive manufacturing linear scale-up

• Use Lean and Six Sigma tools to analyze process trend data and communicate issues using a data-driven approach

• Identify opportunities for process and yield improvement projects

• Anticipate potential issues before they arise by relying on prior experience and new industry knowledge

• Qualify and optimize processes and tooling via IQ/OQ/PQ, Gage R&R studies, process capability studies, and designs of experiments

• Develop and maintain process documentation, including assembly procedures, test procedures, routers, travelers, BOMS, process flows, and process FMEAs

• Utilize Abiomed business systems (SAP) to control bills of materials, manage engineering change orders, and interface to our supply chain process.

• Develop data systems for defect tracking and operator analysis, for process improvements resulting in yield improvement.

• Conduct root cause investigations.

• Apply working knowledge of dispensing processes with adhesives that are critical to component assembly.

• Apply understanding of general properties of adhesives, such as, loctite, epo-tek, etc.

• Ensure compliance with ISO13485, GMP, FDA, OSHA regulations.

Production Project Management

• Act as a project leader for manufacturing improvement projects; preparation of schedules, creation & implementation of program and test equipment and processes according to project requirements.

• Act as a team role model and change agent. Positively lead and influence team members to partner together to achieve individual and business goals.

• Provide prompt problem solving for manufacturing issues, including problem definition, root cause, containment, and corrective and preventive actions.

• Lead investigations of non-conforming product (MRB) and implement action plans for all internal corrective actions and audit findings.