Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention.
Requirements
- Previous experience working with lab/industrial equipment
- Basic understanding of statistical techniques
- Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Solid problem-solving, organizational, analytical and critical thinking skills
- Solid understanding of processes and equipment used in assigned work
- Knowledge of and adherence to Quality systems
- Strict attention to detail
Responsibilities
- Investigate moderately complex manufacturing product quality and compliance issues which may include:
- Investigate PRAs and complaints for manufacturing related issues
- Manage site NCRs, CAPAs, DCRs, and audit observations for all production processes prior to final product release based on engineering principles; analyze results,
- Provide technical support to external and internal audits,
- Make recommendations and develop reports.
- Oversee product release, assess, and disposition product on hold (MRB), and manage material quality control.
- Review and approve equipment validations and asset management actions.
Other
- Bachelor's Degree in Engineering or Scientific field, 2 years’ experience related work experience OR
- Master's Degree or equivalent and internship, senior projects or thesis in Engineering OR Scientific field including either industry or industry/education
- Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast-paced environment
