Manufacturing Engineering Manager, New Product Integration
Date Posted: May 15, 2019
We’re Willow, a team of inventors, mothers, fathers, aunties and uncles on a mission to help women live their best lives. Selected as one of TIME’s 25 Best Inventions, the Willow Wearable Breast Pump is the first all-in-one pump that fits in a bra. This is the first solution in our platform of products that re-imagines how to make women’s lives easier, healthier and fuller.
We’re always on the lookout for talented, passionate team players to help us deliver our mission. If this sounds like you, we’d love to hear from you!
Reporting to the Vice President of Manufacturing, the Manufacturing Engineering Manager, New Product Introduction (NPI) will utilize their technical skills to collaborate cross-functionally, providing leadership and expertise with tech transfer from R&D into a regulated production environment for Willow’s new wearable breast pump and pump-related accessories & products.
This position includes participating in the development of manufacturing process, overseeing the development and procurement of both internal & externally developed technology, performing risk analysis, and verification to specification; followed by, transferring the product into a high-volume, outsourced, manufacturing environment. Efforts will include engaging relevant stakeholders and subject matter experts (SMEs), providing design for manufacturability (DFM) & design for test (DFT), feedback on the proposed ideas, development of protocols and work instructions and the implementation of the design & operational processes.
The successful candidate will directly oversee, the transfer of designs from a lab/clinical environment into mass production with external manufacturing partner setting. The Manufacturing Engineering Manager, NPI will also participate in the development and execution of IQ/OQ/PQ protocols and other required processes and tests, with clinical input, to ensure effective product validation and commercialization of the product.
Essential Duties and Responsibilities:
- Lead Manufacturing Operations workstreams to define, develop, implement, and validate robust and scalable production line(s) scaled with the needed infrastructure and accountability for the necessary deliverables and processes to deliver new products on a regular cadence.
- Work closely with the PMO/project planning and execution for workstream deliverables by ensuring that project schedules are built in collaboration with cross-functional team members and progress is tracked using a Willows Stage Gate process and delivered on-time.
- Collaborate closely with subject matter experts and stakeholders as needed to generate deliverables required for operational readiness such as BOM’s and Functional Test for board-level and device-level procedures up to product launch.
- Advise and present DFx options, recommendations and plans related to design and workstream activities to Senior Operations team members including associated issues and risks.
- Identify and support the development of an effective COGS reduction program.
- Manage both internal and external relationships; such as consultants, components suppliers, contract manufacturers, and logistics partners to ensure effective collaboration and on-time delivery of all associates processes from IQ/OQ/PQ the product.
- Provides assistance/guidance to management on matters related to manufacturing engineering for new product introduction.
- Promotes and maintains constructive interdepartmental and inter-company relationships.
- A minimum of a BS degree in a relevant engineering or scientific discipline and at least 6 years of experience with the operationalization of complex products and workflows including at least 3 years of operational experience with medical devices.
- A fundamental understanding of modern electronics manufacturing processes, flexible and printed circuit board technologies, component selection, test and inspection methodologies with track record of success with their implementation.
- Working knowledge/experience with CAD programs such as: Solidworks, Pro-E, and Unigraphics and experience with PLM/documentation and quality control systems.
- Experience operationalizing new products comprising of electronics + mechanical and plastic sub-assemblies, hardware, and software components in a highly regulated environment (ISO 13485 or FDA 21 CFR 820).
- Experience in cost & quality management, including realistic timeline development and management, risk analysis, and stakeholder communication.
- Demonstrated leadership skills required to align colleagues and stakeholders around a vision and a plan to achieve it, and to then execute the plan.
- A can-do attitude and comfort in a hands-on environment, where you can demonstrate an ability to work with other engineers to influence product design to improve reliability and incorporate design feedback quickly and efficiently.
- Excellent written and oral communication skills and demonstrated excellence in collaborating with colleagues from a wide variety of backgrounds: Engineering, Operations, Quality and Regulatory disciplines.