Senior Sustaining Engineer
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!
We are looking for a Senior Sustaining Engineer who will own and drive existing product designs and value driven engineering for Willow. Qualified candidates will have experience shipping consumer and/or medical products, product design, and manufacturing methods. In addition, empathy for the FDA regulatory, clinical, and quality systems is important.
What you will do:
- Identify, analyze and solve problems pertaining to design and manufacturing processes
- Work with operations and manufacturing to identify and implement design cost reduction and the identification and qualification of new suppliers
- Achieve success goals including: safety, quality, delivery/lead-time, cost/inventory management
- Providing training, direction and engineering support
- Understanding and interpreting engineering and production drawings and procedure. Updating CAD database/drawings as needed.
- Recommend alterations to development and design to improve quality of products and/or procedures. Drive an increase in manufacturing efficiency through analysis of workflow, processes, tooling and equipment
- Collect and analyze relevant process data and to ensure the team’s efforts are in full compliance with company’s quality policies, ISO and other relevant regulations
- Provide supervisory support for members of the sustaining team and act as a mentor for developing engineers. Collaborate within a cross-functional team to define and accomplish the development and validation strategies.
- Provide support to customer service in identifying and addressing critical customer issues. Provide engineering knowledge and critical thinking to the validation of changes that affect the design of existing Willow products.
- Help to redesign established products for greater value and lower cost.
- Provide the knowledge of customer needs and design features to assess and establish the engineering requirements that are essential for the performance and quality of the device.
- Guide the establishment of test criteria and test method development to establish device performance.
- Support design projects for established products targeted to add value, stay current with regulatory requirements, and proactively pre-empt obsolescence.
- Provide leadership and critical thinking to cross-functional teams. Liaison between manufacturing, R&D, marketing, and other cross functional teams.
- Support facility, equipment, product, process validations, troubleshooting and ongoing improvements. Encourage the adoption of best practices throughout Critical Care Operations in areas such as six sigma and lean.
Who we are looking for:
EDUCATION and EXPERIENCE
- Bachelor’s Degree in Engineering discipline; advanced degree preferred
- 7+ years of hand-on professional experience in primarily Medical Device design and manufacturing
- A collaborative mindset, a flexible and friendly approach to working in teams
- Strong understanding of engineering fundamentals, and an ability to deconstruct real world issues into root engineering causes.
- Knowledge of statistics and the application of statistical tools, such as SPC and DOE is preferred.
- Strong verbal and written communication skills are required.
- Knowledge of LEAN principles; Lean Six Sigma Certification preferred
- Prior project management and supervisory experience
- Strong leadership skills
- Ability to travel (10-20%)