Amaranth Medical, Inc. Is Hiring!
Amaranth Medical Inc is dedicated to advancing the practice of medicine and improving the long-term health of patients worldwide. We strive to become the new global standard of care for stent interventions. Our success depends on talented and motivated individuals who share our passion for making a difference in patients’ lives.
We are a young and vibrant company located both in Mountain View, California, and in Singapore. We pride ourselves on a highly collaborative, multidisciplinary environment where initiative and teamwork are valued and individual efforts are recognized. We offer a competitive, comprehensive benefits package.
Competitive Compensation Package
- Competitive salary
- Pre-IPO stock options
- Medical, dental, and vision insurance
- 401(k) plan
- Paid time off (PTO)
Location: Mountain View, CA
Type: Full Time/Exempt
- Reporting to:
- Vice President of Operations
- Summary of Responsibilities:
- The Manufacturing Engineer (ME) will support all aspects of manufacturing, including human-use builds. The ME will be responsible for day-to-day line support as well as process transfer from R&D to Operations. The ME will also be responsible for supporting audits, both internally and from Regulatory Agencies.
- Responsible for the day-to-day engineering support of manufacturing
- Responsible for developing SPC charting for materials, components, and processes
- Generate written reports, charts, graphs to support operations
- Maintaining compliance to cGMP/ISO/QSR systems
- Developing and updating manufacturing documents
- Responsible for the IQ/OQ/PQ of equipment and processes
- Conduct testing and engineering studies for process improvements
- Ensure that manufacturing processes and methods are consistent, cost-effective, and reliable
- Actively work to minimize in-process waste while enhancing product quality
- Support company goals and objectives, policies and procedures
- Support and train technicians and operators on manufacturing processes
- Communicate (written, verbal) and provide updates on manufacturing issues to engineering team and management
- Must maintain a clean, safe, and well-organized work environment
- Experience in Clean Room Operations and Procedures
- Hands-on experience in manufacturing and processing of medical devices, preferable in stent, catheter, and/or coating of devices
- Statistical Process Control (SPC) and/or statistical analysis skills
- Experienced in equipment and process qualification and validation (IQ/OQ/PQ)
- Proficient in technical writing
- Work experience under regulated environment (cGMP, ISO)
- Knowledge of polymers and polymer processing a plus
- Understanding of process optimization and process efficiency
- Minimum 2-3 years in Medical Device Industry, preferable 5+ years
- Minimum BS in Engineering, Chemical or Mechanical Engineering preferred
If you’re looking for a career that enables you to pursue both professional and personal goals, we invite you to consider a career at Amaranth Medical, Inc. Please forward your resumé to email@example.com for consideration.
Amaranth Medical Inc. is an equal opportunity employer.