Miroculus is looking for a motivated, hands-on, and analytical Manufacturing Operations Leader to drive high standards processes for manufacturing of our novel digital microfluidics platform.
Miroculus has re-imagined the paradigm of laboratory testing, so that high quality science can be practiced anywhere in the world. Through the use of their proprietary digital microfluidics technology, Miroculus can automate manually intensive experimental workflows on to a low-cost cartridge, simplifying the preparatory workflow that currently relies on either manual execution or large and expensive robotic instrumentation and making it reproducible and more affordable than ever before.
As the Manufacturing Operations Leader, the individual will act as the main point of contact for external manufacturing partners and vendors, be responsible for setting-up our manufacturing and quality process, oversight of the company’s portfolio of products, ensuring these adhere to company quality standards, customer demand and all regulatory requirements. The individual will participate in negotiations with suppliers to implement proactive production philosophies, improved pricing, inventory health, strategies, policies and procedures.
This position reports to the CTO.
- Lead materials management, supply chain planning and supply chain execution capabilities
- Supervise and lead activities with contract manufacturing groups, vendors and key suppliers, including business, logistics, delivery and technical negotiations
- Oversee and facilitate manufacturing and product quality operations
- Lead manufacturing activities related to design transfer, forecasting
- Build and guarantee the successful execution of manufacturing plans and timelines
- Oversee and assist with ongoing improvements efforts
- Conduct investigations on product build quality, production processes, testing and yield management
- Assess and implement product designs for continued improvements
- Optimize devices for assembly and manage product transfer into production by assisting development efforts
- Ensure that proper documentation is in place including technical writing, standardized documentation and review and improve clarity of documentation as needed
- Initiate purchase orders and amendments for parts, services, equipment and/or special tools
- Arrange for submission and inspection of sample products as required
- Secure and analyze quotations, negotiate prices and terms with suppliers, and recommend suppliers based on cost, quality, and delivery competitiveness for assigned responsibilities
- Own the bill of materials (BOM) and coordinate BOM changes throughout the supply chain and supplier qualification.
- Support qualification and validation activities for manufacturing processes or equipment.
- Demonstrated background focused around medical devices and/or life science, in contract manufacturing, process development, process improvement and manufacturing validations.
- Bachelor’s Degree in life sciences or engineering or related field.
- Over 7 years of relevant experience in Manufacturing Operations and leadership roles.
- Strong analytical skills combined with practical business acumen.
- Demonstrated ability in building relationships across various functional teams.
- Demonstrated ability in managing multiple tasks within tight deadlines.
- Demonstrated ability to exercise influence and informal leadership.
- An approachable individual who provides a high level of teamwork and cross-functional collaboration.
- Travel estimate: 25%
- Experience within a start-up or small manufacturing operation highly desirable.
- Strong project management experience; PMP certification preferred.
- Working knowledge of scientific process and validation methods
- Quality audit experience
- Regulatory Affairs Certification
- Experience with standards such as IEC 60601, 61010, 62304, 62366-1, CE-IVDR, US-IVD, RoHS, REACH, and WEEE.
- Capital equipment assembly and test experience
San Francisco, California
Applicants should send a cover letter and resume to firstname.lastname@example.org
Miroculus believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.