Accountable for leading development and commercialization of combination products and delivery devices supporting AbbVie’s pipeline while providing sustaining support for current and future commercialized products. Provide engineering and business expertise as a leadership team member across a matrixed organization to develop current product improvements and future products. Support, guide and mentor junior and cross-functional team members in the art of combination product development to enhance AbbVie’s overall business.
- Accountable for AbbVie`s product portfolio and technology development of combination products and delivery devices.
- Lead and develop drug device combination product strategies as a multidiscipline expert.
- Program Champion – Establish and act as the program champion between the technology purveyor and AbbVie. Be the diplomatic tie and foster the partnership relationship with goal of obtaining “win-win” for both.
- Lead the technical development with respect to specification, design, documentation, and verification / validation through product transfer to commercialization and launch. Successfully balance and integrate the differences between partners’ and AbbVie’s operational, quality and documentation systems.
- Establish collaborative working relationships with vendors, provide effective oversight of suppliers, manage technical aspects of the device partner/suppliers, combination product fill and finish CMOs together with Drug product lead, contract device assembling, packaging, human factor, and/or usability development organizations.
- Coordinates strategy and approach for Design Control documentation across projects, leveraging platform strategy.
- Build effective relationships with cross-functional management and leadership team members.
- PhD or Masters of Science in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Electrical Engineering or a similar field.
- 10+ years of experience in product development or engineering (PhD).
- 16+ years of experience in product development or engineering (Master of Science).
- Significant experience with medical device or combination product commercialization, operations support, and materials/components.
- Proven track record of successful cross-functional leadership developing and launching new products.
- Demonstrated success in providing strong technical leadership and strong partnering with Marketing, Commercial, Product Management, Operations, and QA/RA.
- Proven leader in devising and implementing streamlined processes to improve efficiency, timeliness, and productivity.
- Ability to align and manage multiple projects simultaneously and achieve scheduled milestones; demonstrate risk project management, including contingency planning.
- Ability to guide technical resources in the translation of marketing requirements into design specifications.
- Ability to provide technical leadership in material and component selection to mitigate technical and supply chain risks.
- Familiar with regulatory requirements for combination products worldwide, with experience in FDA regulations and EU-MDR and Notified Bodies.
- Experience authoring documentation associated with Design Controls and Notified Body Opinions requests.
- Attention to detail and an ability to absorb and assimilate information rapidly.
- Strong team-working and communication skills.
- Strong competency using office software including MS Word, Excel, MS Project, and PowerPoint.
- Strong collaborative skills, creative problem-solving, keen attention to details and outstanding organizational abilities.
- Excellent written and spoken command in English language.
Travel: Yes, 15 % of the Time
Job Type: Experienced