The Senior Engineer will lead technical efforts for drug delivery device projects. As a hands-on technical leader and device subject matter expert (SME), this person will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, equipment development oversight. Extensive collaboration with internal and external partners.
Responsibilities (% of time):
- Provide technical leadership on cross functional teams for devices through clinical development, product registration and commercialization. Own and lead the creation of design control deliverables to comply with medical device and combination device regulations. – 50%
- Establish and maintain detailed project plans, define risks and recommend contingency plans as required. 20%
- Lead project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation. – 20%
- Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. 5%
- Lead or assist in deviation, complaint and failure investigations. 5%
- More than 5 years’ experience in the field of medical device or combination product development and commercialization is required.
- Proven track record of developing wearable injectors and/or infusion pumps preferred.
- Prior technical leadership experience with automation equipment development and manufacturing scale-up a plus.
- A Bachelor’s of Science Degree in Engineering required, a Master’s of Science Degree preferred.
- Experience in developing and commercializing regulated devices / combination products under Design Control (21 CFR 820) and ISO14791 requirements.
- Proven track record of developing and gain regulatory approval of drug delivery systems a plus
- Knowledge of global industry standards (ex: ISO, AAMI, ANSI, etc..).
- Strong hands on technical leadership skills with a track record of delivering new products to market.
- Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences, is desirable.
- DFSS certification is highly desirable.
- Prior experience leading projects with external design, development and manufacturing partners.
- Working knowledge of solid works desirable.
Key Skills & Abilities:
- A strong knowledge of developing and commercializing FDA regulated devices / combination products under Design Control regulations and ISO14971.
- Extensive knowledge of engineering principles, concepts and applications.
- An aptitude for project foresight and contingency planning.
- Effective planning and organizational skills.
- Excellent writing and oral communication skills.
- Strong knowledge of project management techniques, tools and metrics.
- Ability to mentor technical and cross functional team members.
- Strong collaboration skills with external partners.
Location/Region: Lexington, MA