Process Engineer 7/26/2018
JOB DESCRIPTIONAPPLY Abiomed, an innovative medical device company, is focused on recovering hearts and saving lives. We have a single guiding mission: Patients First. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed s 1,000 employees form one of the fastest growing medical technology companies in the world. Abiomed attracts and retains exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.
The Process Engineer will design, develop, improve and validate manufacturing processes, tooling, and fixtures in order to meet daily and long range production schedules. This key role will support the manufacturing engineering and NPI teams with documentation of manufacturing processes, engineering change orders (ECO), validations, technical procedures, equipment, tooling, and fixtures.
Principal Duties and Responsibilities:
* Develop and update process documentation including assembly procedures, work instructions, test procedures, validation protocols and reports, routers, travelers, BOMs, process flows, and process FMEAs
* Assist engineering team to qualify and optimize processes and tooling via IQ/OQ/PQ, preventive maintenance, Gage R&R Studies, Process Capability Studies and Designs of Experiments
* Regularly report on project status, schedule progress and key project metrics through scorecard presentations
* Identify opportunities for process and yield improvement projects
* Support prototype, V+V, pilot and commercial production of new products, product changes, and enhancements in coordination with Operations, Product Development and Quality Assurance organizations.
* Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations
* Participate in the implementation of internal corrective actions and audit findings
* Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical, technical, and biomedical developments related to company products.
* International travel (5-10%) required in support of these duties and responsibilities
* Bachelor s degree in engineering
* 0-2 years related experience required, medical device experience preferred
* Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team and international
* Proficiency with Microsoft Office Suite
* Willingness and ability to travel internationally 5-10% of the time in support of the position s duties and responsibilities
* Medical device experience preferred
* Knowledge of FDA QSR and ISO regulations strongly preferred
* Working knowledge of SAP desired
ABIOMED is an Equal Employment Opportunity/Affirmative Action employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.