Senior Quality 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!
Responsible for working with cross-functional teams by providing quality engineering support and leadership for quality related functions for all aspects related to manufacturing and new product development. Responsible for assessing compliance with the quality system that includes compliance with applicable international standards and regulations (i.e., ISO 13485, MDD and QSR). Assist with implementing and evolving various aspects of the Quality System.
MAJOR DUTIES & RESPONSIBILITIES:
- Provide Quality Engineering support for design control process (e.g., verification and validation activities, risk analysis, etc.) for product development projects
- Work with R&D to develop device specifications and test methodologies.
- Develop strategies and execute on required quality testing to support product development (e.g. sterilization validation, biocompatibility testing, packaging testing, IEC 60601 testing etc).
- Assist with the manufacturing transfer of the product from R&D into production, including setting up inspection instructions and required documentation.
- Prepare for and participates in Management Reviews.
- Participate in FDA and other regulatory agency audits.
- Interface with European Notified Body on ISO 13485/CE Mark matters.
- Position will require some travel to other locations, supplier sites etc.
- Experience working with contract manufacturers (US, International)
- Hands-on experience in Medical Device product quality assurance and quality engineering functions
- Knowledge of design control requirements and necessary activities
- Thorough knowledge of QSR, ISO 13485, MDD requirements
- Able to support development of products from initial concept to commercial product
- Experience with supporting electro-mechanical device development and production
- Attention to detail, good organization skills
- Good communications and interpersonal skills, teamwork, ability to multitask
- Bachelor’s degree in Engineering or equivalent experience
- Minimum of 8 years related experience
- Direct experience with start-up medical device development that resulted in successful commercialization
- Previous experience with embedded software