Amaranth Medical 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
- Generous paid time off (PTO)
Position Title: Sr. Quality Engineer
Reports To: VP, Quality Affairs FLSA Status: Exempt
Summary of Responsibilities: Ensures that all Quality System activities are conducted and documented in accordance with appropriate industry, regulatory standards and Company procedures.
- Provide quality input/oversight supporting new product development and daily operations for the scaffold and delivery system manufacturing operations.
- Support all phases of the product design and manufacturing process development; incoming inspection, in process and finished product test.
- Assist in development of test specifications, protocols, sampling criteria and documentation activities to support all design and manufacturing functions.
- Ensures tests are compliant to established Standard Operating Procedures (SOP), Good Manufacturing Practices (GMP) as well as any applicable federal or international regulations and/or standards.
- Perform equipment, operational and performance qualification studies to verify each complies with design, operational and business expectations.
- Communicate effectively with Project Team members and Amaranth management.
- Ensure proper documentation of design/manufacturing changes (e.g. change control, data traceability) and integrity of data, calculations and results reporting in accordance with the internal Quality documentation system.
- Support the maintenance program for key test equipment and the ability to perform Gauge R&R studies on key instruments.
- 5+ years of industry experience in drug/medical device development or product development or combination devices.
- Understand FDA and notified body regulatory audit requirements.
- Observe and comply with site level quality policies, procedures and work instructions.
- Mentor and lead other team members in performing good quality manufacturing practices.
- Be a positive, self-confident, decisive with excellent communication skills in both oral and written formats, as well as excellent listening skills.
- Be known as a person who has high integrity, sound character, a tremendous work ethic, excellent team player, and the passion to succeed.
- MS or BS Engineering and/or Science related field
- Relevant Quality Assurance experience desirable
Position Title: Manufacturing Manager
Reports To: VP, Operations FLSA Status: Exempt
Summary of Responsibilities: Develop and implement build plans and schedules, provide leadership to manufacturing team, scale-up and commercialize processes and facilities.
- Develop and implement daily production schedules and builds.
- Oversee manufacturing personnel, schedule tasks, provide leadership, and conduct employee evaluations.
- Develop scale-up and commercialization plans, including facilities and support.
- Execute on scale-up and commercialization plans.
- Develop, apply, and review documentation consistent with ISO/cGMP requirements.
- Develop and implement material product/process flow and handling.
- Monitor processes via SPC, defect pareto charts, histograms, etc.
- Ensure equipment is qualified, calibrated, and maintained (PM scheduled).
- Maintain facilities and clean rooms (particulate, bioburden, consumables, etc.).
- Ensure production materials are on-hand, in supply, and Kanban maintained.
- Support commercial operations in Singapore and California.
- Generate written reports as needed.
- Complete projects (including product enhancements) in a manner consistent with corporate objectives.
- Develop, monitor, and adhere to timelines for assigned projects.
- Support company goals and objectives, policies and procedures, QSR, and FDA regulations.
- Communicate in writing and/or verbally project updates, problem descriptions and resolutions and other issues with engineers and senior management.
- Assist R&D/engineering team as required.
- 5-10 years of medical device experience and/or regulated environment experience.
- Working knowledge of ISO and cGMP standards.
- Use sound judgement and structured decision-making techniques to implement solutions.
- Work within budgetary constraints.
- Work successfully with different functions and all levels of the organization and between sites.
- Work independently to accomplish short and long-range projects, anticipate likely needs, and recommend actions with minimal direction.
- Communicate effectively.
- Ability to work independently to resolve complex issues.
- Proficiency with Excel, Word, PowerPoint, Statistics and other software as necessary.
- BS in Engineering or Chemistry or equivalent required