Sr. Production Engineer I

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!

Abiomed has an immediate opportunity for a Sr Production Engineer I in our Fiber Optic Sensor Operations group.  Located in Woburn, MA, this individual will develop, improve, validate, and scale up our company's manufacturing processes, tooling, fixtures and equipment in order to meet daily and long-range production schedules. 

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

Job Qualifications:

• Bachelor’s degree in Mechanical Engineering, Industrial Engineering, or a closely related Engineering field required, advanced degree preferred
• 5+ years of experience required
• Demonstrated leadership in a process or manufacturing engineering capacity
• Exceptional project coordination skills while being able to multi-task and meet multiple project schedules on time
• Demonstrated knowledge of Lean, Six Sigma, or continuous improvement initiatives
• Demonstrated knowledge of Minitab (or equivalent) skills
• Familiar with statistical process control principles, Gage R&R measurement, and SPC tools
• Demonstrated ability with analyzing statistical parameters leading to quantifiable solutions
• Strong verbal and written communication, analytical/problem solving, negotiation, and interpersonal skills
• Familiarity presenting on and explaining projects at all levels of the organization
• Demonstrated knowledge of FDA, QSR and ISO regulations

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.