Sound good so far? It really is!
We are inclusive, prize ingenuity, and are united by a common mission to rapidly advance transformative medicines for patients who cannot get them soon enough.
Our values – focus, ingenuity, tenacity, transparency and fun – form the fabric of the organization. They are reinforced daily and serve as key dimensions in the hiring process to help us ensure that Flexion is a magnet for outstanding talent and a great place to work.
Join our team as a Medical Device Engineer. This is a great opportunity to make an immediate impact and work at one of the Boston Globe's Top Places to Work 2017 and Boston Business Journal's Best Places to Work 2017 AND 2018!
As a Medical Device Engineer in the CMC group at Flexion, you will work closely with internal project teams to effectively manage existing combination product programs in addition to contributing to new medical device programs for life cycle management and pipeline products. You will manage external medical device vendors, maintain the Design Control programs for Flexion’s combination products, and participate in Flexion’s cross-functional combination product development efforts. The engineer in this role will need a deep understanding of Flexion’s products and how medical devices can be incorporated to enable improved user experience and/or product performance. The ideal candidate will be a detail oriented device engineer with experience working on a commercial stage combination product program.
The Opportunities Are Endless!
Our Ideal Candidate Will Have:
- Manage external medical device vendors for new and existing commercial combination products
- Create and maintain Design Control programs (including Design History Files and Risk Management Files) for Flexion’s combination products
- Participate as an integral member of cross-functional product teams by contributing ideas as well as designing, managing or executing, and interpreting device development activities
- Perform landscape searches for existing relevant medical devices that may be valuable to Flexion
- Present project plans and research findings at group meetings, department meetings, and to senior management
- Author documentation as part of development under Design Control including requirements documents, specifications, test plans, test reports, and risk assessments.
- Support technology transfer for Flexion products to/from contract manufacturers
- Bachelor’s degree in relevant engineering field (Mechanical, Chemical, Biomedical, or equivalent) .
- At least 3 years of engineering experience (Mechanical, Chemical, Biomedical, or equivalent).
- At least 5 years’ experience on a commercial combination product team
- An advanced degree is a plus.
- Experience in establishing and maintaining Design Control (21 CFR 820) for a combination product including the development of Design History Files and Risk Management Files
- Experience managing medical device vendors
- Excellent attention to detail and ability to successfully and independently manage multiple simultaneous projects
- Proven ability to learn and act on dynamic information at a rapid pace
- Outstanding written and verbal communication skills
- Enjoys working in a fast-paced, small-company environment
- Excellent interpersonal skills with the ability to work effectively with cross-functional peers
- Willingness to “roll up your sleeves” and contribute in areas outside of your defined role
- Ability to occasionally travel domestically and internationally
- Experience with medical devices for injection (injection systems, pre-filled syringes, others) is desirable
Thank you for taking the time to learn more about us. If this is something that sounds interesting, we'd love for you to apply below.