The Lead will lead Shire’s cross functional Combination Device Development efforts and Qualification of Medical Devices used in clinical studies. The ideal candidate will be a hands-on project and technical leader, considered a device subject matter expert (SME), and will provide project and engineering leadership in the device identification, feasibility, development, qualification and launch of combination products. Area of focus will also include identification of user needs, specification development, test development, design verification and validation testing, risk assessments, and project team oversight with extensive collaboration with internal and external partners and stakeholders.
Responsibilities (% of time):
- Provide project and technical leadership to cross functional teams for projects through clinical development, product registration and commercialization. – 25%
- Establish and maintain detailed project plans, define risks and recommend contingency plans as required. 25%
- Lead all project execution activities and oversee the development of statistically sound design verification protocols/reports, design validation, and delivery system qualification activities. – 25%
- Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers. 20%
- Support the optimization of design control elements to comply with medical device regulations Lead or assist in deviation, complaint and failure investigations. – 5%
- More than 10 years experience in the field of medical device or combination product development and commercialization is required.
- Proven track record of developing reconstitution devices preferred.
- A Bachelor’s of Science Degree in Engineering required, a Master’s of Science Degreepreferred.
- Minimum of 7years leading cross functional teams and projects.
- 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 products to market.
- Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary audiences, is required.
- DFSS certification is highly desirable.
- Prior experience leading projects with external design, development and manufacturing partners.
- Prior experience managing and mentoring direct reports desirable.
Key Skills & Competencies:
- 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.
Req ID: R0019095