Npi Operations Project Lead

Abiomed ist ein innovatives Medizintechnik-Unternehmen und hat sich dem Firmenmotto „Recovering Hearts, Saving Lives“ verschrieben. Wir haben einen einzigen Leitsatz: „Patients First“. Abiomed hat seinen Firmenhauptsitz in Danvers, Massachusetts und Niederlassungen in Aachen und Berlin, Deutschland sowie in Tokio, Japan. Mit 1.700 Mitarbeitern ist Abiomed eines der am schnellsten wachsenden Medizintechnik-Unternehmen weltweit. Abiomed ist ein attraktiver Arbeitgeber, der durch die Kultur der Zusammenarbeit, Leidenschaft und Einsatz für die Weiterbildung der Mitarbeiter außerordentliche Talente begeistert und bindet. The NPI Operations Project Lead will be responsible for planning and driving implementation of new product changes and risk mitigation measures into production in collaboration with development and operations. They will lead the transition of new products and approaches into production by pushing design for manufacturability early in the design phase and pulling product into production when the design is complete. **Responsibilities**: - Lead transfer of new design changes, processes, and risk mitigation measures into production in collaboration with development and operations team - Influence design specifications to achieve the best quality, cost, yield and cycle time such that business goals and objectives are met - Identify and manage cross-project dependencies by mitigating any identified risks by engaging with key stakeholders early in the process. - Create manufacturing strategies with input from stakeholders and the project core team to support product qualification and validation builds. - Develop and qualify manufacturing processes and tooling via IQ/OQ/PQ, gauge R&R studies, and process capability studies by partnering with engineering team - Develop and implement process documentation (assembly procedures, test procedures, routers, travelers, process flows, and process FMEAs) in conjunction with operations team - Communicate project status, schedule progress, milestone and critical path towards goals and objectives in collaboration with functional team. - Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations. **Requirements**: - Bachelors or Masters Degree in Engineering. - 5+ years of relevant work experience with demonstrated project management skills (medical device experience preferred). - Ability to work well in a global cross-functional team environment with excellent communication skills. - Hands on capability with good knowledge of medical device manufacturing processes. - Experience with statistics, statistical tools/techniques. - Willingness to travel internationally up to 25% travel to support position’s responsibility. - Project management certification and proven track record of implementation - Six Sigma Green Belt (Black Belt preferred) certification - Experience in developing and implementation of products under FDA control **We offer**: - Pleasant, open corporate culture with a strong mission: "Recovering Hearts, Saving Lives" - Comprehensive induction program with structured onboarding plan throughout the orientation phase - Company pension allowance of up to 1,500 euros per year and capital-forming benefits - Abiomed shares at a preferential price - Benefit packages for occupational disability insurance and company group accident insurance - Full cost coverage for a job ticket in the Aachen or Berlin area - Various health programs and a leasing option for a job bike ABIOMED is an Equal Employment Opportunity employer. We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, disability or national origin.