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Sr Mechanical Engineer I

Date:  May 26, 2021
Location: 

Halethorpe, MD, US, 21227

Abiomed is a pioneer and global leader in healthcare technology and innovation, with a mission of Recovering Hearts & Saving Lives. With corporate headquarters in Danvers, Massachusetts, offices in Aachen & Berlin, Germany and Tokyo, Japan, Abiomed’s 1,700 employees form one of the fastest growing medical device companies in the world. We attract and retain exceptional talent with our collaborative culture, passion for our work, and a strong commitment to employee professional development.

 

Patients First | Innovation | Winning Culture | Heart Recovery
 

 

Breethe Inc., a new acquisition of Abiomed Inc., is based in Baltimore Maryland and develops portable artificial lung devices (ECMO) that transform clinical practice and improves outcomes of those who suffer from acute and chronic lung problems. We are hiring for an exceptional Senior Mechanical Engineer to join our team of world-renowned experts and product development engineers. Be a part of our innovation that will improve the lives of others.

Responsibilities include working through all aspects of the development process including requirements definition, design for manufacture, implementation, test, qualification and documentation. Experience with medical device disposables, robotic gluing, curing and potting process is a plus. This person must of excellent communication skills and works well in a team environment with both internal and external resources.

 

Primary Responsibilities

• Lead manufacturing fixture development, process development and qualifications

• Subject matter expert on unique manufacturing process from both a design and process perspective

• Technical lead on manufacturing process flow and design transfer

• Author and maintain manufacturing specifications, requirements, and Process Failure Modes and Effects Analyses (PFEMA)

• Author and lead process qualification via IQ, OQ & PQ process. • Technical lead on design transfer in partnership with contract manufacturers.

• Conduct and lead failure investigations.

• Ensure document management and manufacturing control compliance.

• Conduct and manage structured design reviews.

• Work as an integral member of the product development team throughout the product lifecycle, working with hardware, software and firmware engineers, user experience specialists and system engineers

 

Requirements

• Familiarity with modern verification/validation methods • Knowledge of manufacturing documentation, engineering test protocols, engineering laboratory procedures. • Experience with managing and communicating with outside suppliers, manufactures and consults is essential.

• BS Engineering

• Minimum 10 years of experience in a regulated design and development or manufacturing/operational environment.

 

 

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.


Nearest Major Market: Baltimore