Abiomed Danvers , MA 01923
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.
Are you excited by the idea of a lead role in new product development at one of the fastest-growing medical device companies in the world? Would you feel proud to ensure the technical viability of industry-leading Class III medical devices that are saving the lives of patients worldwide? If so, consider the following Principal Product Development Engineer opportunity with ABIOMED!
Working cross-functionally, this person will be a subject matter expert, and a leader on the Development team - providing direction to team members in the development of new products, and providing engineering expertise to support the business. The Principal Product Development Engineer will lead complex technical development efforts, design initiatives and engineering / product development methodology improvements to drive development initiatives at ABIOMED.
Provide product development expertise leading Impella pump and system design and engineering initiatives.
Provide technical direction and leadership, drive development efforts, and chair project team meetings.
Manage technical and programmatic risk, ensuring effective risk identification, assessment and mitigation.
Prepare design reviews and present to peers and review team. Ensure the technical integrity of the product design.
Establish design goals and specifications based on requirements and user needs.
Perform design-trade-offs to define system architectures.
Perform mechanical, fluid, vibration, thermal, reliability, magnetic and systems analyses to support new and existing designs
Fabricate prototypes with assistance from junior staff, technical support team (Machine Shop, Technicians and Designers) and suppliers
Document designs by constructing solid models and drawings with Solidworks using GD&T and stack-up analyses
Work with internal and external manufacturing partners to ensure producible designs (DFM)
Participate & Lead brainstorming efforts to identify potential solutions.
Create work breakdown structures the leads to robust project plans and critical path tracking.
Effectively communicate activity status, issues and mitigation plans with key stakeholders.
Collaborate to ensure compliance with design controls, company quality policy and applicable regulatory requirements.
Mentor junior staff for timely completion of tasks per plan without direct supervision
Suggest, contribute and champion initiatives to improve the Engineering Department's operations and procedures.
Bachelor of Science degree in Mechanical, Biomedical Engineering or directly related scientific discipline
12+ years of related engineering or product development experience (8+ years' experience with Master's degree, 6+ years with PhD)
History of applying fundamental concepts of mechanical design & material properties to drive product development
3D modeling experience (Solidworks preferred)
Experience using advanced analytical methods (FEA, fluid dynamics, tolerance analysis)
Experience analyzing designs early in development to mitigate risk
Experience applying statistical analysis
Six Sigma and/or Design for Six Sigma certification or experience
Strong problem solving skills and experience identifying root cause
Demonstrated ability to use sound judgment and decision-making in balancing costs, schedules and quality objectives
Willingness & ability to travel domestically & internationally (E.U.), up to 20% of the time
Medical device experience preferred
Knowledge in medical device clinical use, design controls and regulating standards
Advanced degree (Masters or PhD)
Experience planning/executing acute or chronic animal studies, or other in-vivo evaluations, is a plus
Green Belt Preferred
Knowledge of cath lab and/or cardiothoracic/vascular surgical environments
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.