Are you excited by the idea of a leadership role on the Process Engineering team at one of the fastest-growing medical device companies in the world? Would you feel proud to contribute to the manufacturability of industry-leading Class III medical devices that are saving lives across the globe? If so, consider the following Senior Process Improvement & Development Engineer opportunity with ABIOMED!
The Senior Process Improvement & Development will play a leadership role on the Process Engineering team, ensuring that production operations are maintained and optimized. This role will lead initiatives, provide direction to more junior staff, identify gaps and propose innovative solutions to support the business.
JOB DESCRIPTION
The Senior Process Improvement & Development Engineer will design, develop, improve and validate manufacturing processes, tooling, and fixtures in order to meet daily and long range production schedules. They will regularly report on project status, schedule progress and key project metrics through scorecard presentations, action items, meeting minutes, and manufacturing readiness reviews with program and operations management; oversee outside supplier activity and technical issues to meet production demand; and maintain accurate documentation of concepts, designs, and processes while preserving current knowledge of medical, technical, and biomedical developments as related to Abiomed products. Some international travel will be required.
KEY RESPONSIBILITIES
Control manufacturing processes while reducing defects and enhancing productivity and product quality
Use Lean and Six Sigma tools to analyze process trend data and communicate issues using a data-driven approach (obtain statistical data, analyze data, and recommend courses of action based upon quantitative results)
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
Mentor peers on areas of engineering expertise while acting as an agent of change focused on improving technical skills and system knowledge
Support global projects, production floor support, and product development design transfer efforts through recurring meeting coordination/attendance and, if needed, international travel between facilities, ensuring corporate objectives are met in a timely manner
Ensure company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations are met
Develop and maintain process documentation (assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs)
Participate in the investigation of non-conforming product and implement action plans for all internal corrective actions and audit findings
Skills/Requirements
QUALIFICATIONS
BS in engineering or statistics required; MBA, MS or other advanced degree preferred
7+ years of related work experience required
Demonstrated leadership in a process or manufacturing engineering capacity is required
Knowledge of Lean, Six Sigma, and continuous improvement initiatives required; Green Belt strongly preferred
Minitab (or equivalent) skills and proven exceptional experience analyzing statistical parameters leading to quantifiable solutions
Intimate knowledge of FDA, QSR and ISO regulations
Ability to exercise judgment in selecting, methods, techniques, and evaluation criteria for obtaining results
Microsoft Office Suite proficiency required; working knowledge of SAP desired
Ability to travel internationally (10%-20%) is required
ABOUT US
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.
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.
