• Assist in the design and development of new or enhanced stent grafts and delivery systems from pre-clinical development through product commercialization.
• Assist in developing and ensuring execution of rigorous testing of projects by designing thorough test plans (i.e. experimental design, data evaluation, generation of scientific reports).
• Excellent teamwork and organizational skills.
• Collaborates with R&D, Manufacturing, Regulatory and Quality departments to coordinate focused efforts on investigations and resolves issues associated with product or other technical related issues.
• Demonstrate the ability to provide technical procedure/direction and interact professionally and effectively with senior management, peers, team members, supervisors, outside customers, and other teams/departments on an ongoing basis to ensure product development success. Document all work according to GMP and SOPs.
• Conducts testing to verify that the design meets the engineering specifications.
• Assess failure modes and conduct technical risk analysis.
• Document engineering work in compliance with the company's quality system.
• Identifies hazards and mitigates risk associated with identified hazards in Design and Process FMEA.

• May develop procedures and processes within broader protocols.

• Conducts or manages research, analysis or processes within a larger R&D activity.

• May develop and implement standards for operations and reporting.

• Ensures completion of activities within compliance and on-time.

• May identify and implements process level efficiencies.

• May be responsible for operating within a budget.

• May provide work instruction or supervision to team resources of professional and technical employees for initiatives and projects.

• Perform other duties as assigned by supervisor.

Education:

• Bachelor's degree in Mechanical Engineering, Bioengineering from a four-year college or university; or related major in Life Sciences preferred.

Experience:

• 2-3 years in medical device manufacturing, development, testing, or designing, GMP, FDA, and ISO requirements and experience writing protocols, test plans, and test reports.