Operations Science & Technology Combination Products supports technical and scientific activities related to design development, transfer and on-market design management of medical devices and drug delivery systems supporting combination products at AbbVie. The director leads and directs others in technical projects including development, manufacturing and design changes. Product types vary and include plastic disposable and implantable products and electromechanical devices with integrated software. The position is responsible for technical leadership, establishing goals that are consistent with development, manufacturing and customer requirements, implementing plans/policies, assigning duties and responsibilities, and managing employee performance to meet division goals and commitments. Projects and programs include product design, design transfer from development to manufacturing, troubleshooting of product and process failures, and contributing to regulatory submissions, in compliance with device design controls (FDA 21CFR820.30 and/or ISO 13485). The director will be responsible for establishing technical partnerships with AbbVie manufacturing sites and product partners and contributes to product lifecycle strategies and plans. In addition, the position will have responsibility for developing product knowledge and building capabilities especially in the area of software driven electromechanical products. Experience with combination products and especially medical device design and manufacture is required.
- Provide mature, credible medical device leadership at AbbVie
- Provide a positive leadership model for scientists and engineers within Operations Science & Technology. Maintain and direct a highly diversified cross functional staff of professionals to insure that all aspects of product life cycle management are completed on time, within budget and meet highest scientific, regulatory, quality, marketing and commercial standards
- Evaluate and introduce new technology and apply advanced scientific and engineering analysis to applications in development and manufacturing while assuring the incorporation of knowledge of current regulations, guidance documents and competitive environment into decisions and strategy
- Provide rapid and accurate evaluation of new business opportunities
- Develop and communicate cost estimates, business plans, timelines and contingency plans
- Identify and recruit resources to accomplish project and departmental objectives within agreed time scope, and operating in an open communication environment whilst stressing scientific/compliance excellence Planning, maintaining and managing a departmental salary budget, an operating budget and project budgets Participate in capital planning and capital project execution to advance the department
- Make go/no-go decisions related to project responsibilities
- Represent AbbVie to regulatory agencies (US/ROW as appropriate) by supplying verbal or written information and/or participation in face-to-face meetings for responsible activities Establish, maintain and foster good working relationships with internal stakeholders and business partners. Provide effective technical and business leadership at the R&D/Operations interface.
Level of Leadership Activities:
- Coordinates strategy and technical activities of the project team
- Champions new technologies demonstrate applicability departments/business units
- Reviews and critiques technical documentation, regulatory submissions and presentations for others. Consistently and effectively presents complex technical data to large and diverse groups.
- Trains and develops others using a variety of techniques. Advances the level of technical expertise within the division. Establishes project operation criteria and technical standards for excellence. Generates new product ideas consistent with company strategy. Prepares and aligns impact goals with department and cross-functional goals.
Level of Interpersonal Skill:
- Leads cross functional teams. Maintains and develops broad external and internal contacts to maintain technical knowledge as required to accomplish strategic needs of the division.
- Has demonstrated technical leadership in a multi-disciplinary environment.
- Mentors others by sharing technical expertise and providing feedback and guidance. Provides direct reports with tasks / project assignment opportunities for employee development and evaluates performance.
- Establishes networks. Follows through on project goals; contributes willingly and incorporates the ideas of others; shares resources, knowledge and accountability to benefit the objectives of the business, e.g. participates in team meetings; serves either as functional subject matter expert or independent technical expert in design reviews.
- Master’s Degree or equivalent related experience in Chemical, Biomedical, Mechanical or Materials Science Engineering or related field. PhD or equivalent experience in a related scientific discipline is highly desired.
- The incumbent would be expected to have10+ years of experience in medical device design, development and operations technical services roles, including at least 6+ years of managerial experience in the pharmaceutical or medical device industry.
- Strong background and expertise in product development, marketed product support, technical issue resolution & related technical, manufacturing, regulatory and compliance fields.
- Biomedical or mechatronics experience strongly preferred, drug product development experience a plus.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced