This individual is a senior level technical leader for the design and development engineering of class III disposable vascular access introducers and closure devices to support Abiomed’s Impella product line.  This position is responsible for leading and delivering on large scale projects. The individual must independently plan and manage his own, and other team members work activities to achieve program objectives both within Abiomed and in coordination with external strategic development partners. 

Those activities include both technical and project activities with primary accountability and responsibility for project definition, deliverables of the disposable design, and throughout the field release of the product. The individual is also responsible for ensuring that the design complies with the company’s quality policy, as well as all applicable regulatory and notified body requirements.

Responsibilities

• Work with product management to carryout VOC investigations.  Collect, analyze, and document user need results; lead brainstorming efforts to identify potential solutions.
• Provide disposable expertise and technical leadership on the project and execute on program management requirements and deliverables.
• Ability to lead cross-functional technical teams to achieve project objectives.
• Independent analysis of solutions for product performance and use problems, exhibiting creativity, foresight, innovation, and judgment in anticipating and solving these problems.
• Lead design reviews that prevent design errors and ensure design and process development will meet requirements.
• Establish and execute the technical development plan, process, and design strategy.
• Manage technical and programmatic risk, ensuring effective risk identification, assessment, and mitigation; especially as it applies to biological, sterilization/contamination, and other patient risks.
• Effectively communicate activity status, issues, and mitigation plans with key stakeholders.
• Manage the successful hand-off the product to in-house or OEM manufacturing teams.
• Ensure the technical integrity of the product design.
• Efficiently address, identity the root cause, and resolve any field issues which may arise.
• Work with Industrial Design and Human Factors experts to deliver best-in-class product designs.

Job Requirements

1. Bachelors of Science degree in Mechanical or Plastics engineering, MS degree preferred.

2. Minimum of 5 years’ experience in the design of complex medical disposable products.

3. Knowledge of medical clinical use of disposables and regulating standards.  Experience with cath lab and/or cardiothoracic/vascular surgical environments.

4. Extensive working knowledge of plastic processing including: injection molding, extruding, solvent and thermal bonding, and other related processing methods.

5. Knowledge of sterile disposable product and packaging design principles and best practices

6. Knowledge of material characteristics; specifically engineering polymers.

7. Experience applying fundamental concepts of mechanical design and statistical analysis.

8. Demonstrated history of creating concepts and functioning designs for complex plastic mechanism, linkages, and actuators as part of catheter based delivery devices.

9. Ability to conduct and drive empirical modeling and analytical testing activities.

12. Demonstrated history of meeting the expectation and requirements of internal customers.

13. Demonstrated history of meeting or exceeding goals and getting results.

15. A history of sound judgment and decision-making in balancing cost, schedules and quality objectives.

16. Technical leadership and mentoring skills with a clear high performance orientation; demonstrates energy, enthusiasm, and creativity in problem solving.

17. Proven leadership and teamwork skills in a cross-functional engineering environment; ability to motivate and empower team members; set and manage expectations.

18. Demonstrated performance building and leveraging partnerships.

19. Significant 3D modeling experience (Solidworks preferred) with history of utilizing advanced analytical methods such as FEA, mold-flow, and tolerance analyses to mitigate risk during early development phases

20. Experience in planning/executing acute and/or chronic animal studies

ABIOMED is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Veteran/Disabled.