Manager, Engineering Test and Analysis Group, Combination Product Development
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
AbbVie's Combination Product Development (CPD) organization is looking for a Manager for the Lake County (LC) Engineering Test & Analysis Group (ETAG). The Manager, ETAG will play a crucial role in the development and launch of drug delivery systems by planning, executing, and delivering on testing needs across AbbVie's pipeline assets.
We are seeking an engineering professional who can apply his/her engineering knowledge and ingenuity in the planning and execution of testing while providing robust documentation in accordance with regulatory needs. The Manager, ETAG will manage a team of combination product (medical device) engineers at our Lake County test site. He/she will ensure coordination of activities between CPD groups in LC (Lake County, USA), LU (Ludwigshafen, Germany), and CA (California, USA) to leverage and optimize site capabilities.
- Responsible for leading a team of engineers, technicians, and contractors ensuring optimal resource utilization and allocation across programs and projects, and forecasting resource needs based on planned activities.
- Responsible for providing laboratory support, as well as building capabilities within the department. Lab support includes managing medical device test preparation and execution activities, as well as supporting internal and external audits.
- Responsible for ensuring the lab equipment maintenance and calibration schedule is sustained.
- Manage the Design Verification process for multiple devices/combination products such as auto-injectors, on-body delivery systems, and infusion pumps for both clinical studies as well as commercial approval and launch to ensure the device meets design requirements and comply to global regulations (FDA, MDR, etc.). The process includes creation of verification plans, protocols, and reports.
- Manage the team and activities associated with defining, developing, and validating test methods using lab equipment to perform engineering confidence testing and design verification testing. Test method validation ensures the procedure or method is suitable for its intended use to consistently produce reliable analytical results.
- Drives and/or participates in department continuous improvement initiatives focused on maximizing process efficiencies, and enhanced collaboration within and outside of the department.
- Engage and collaborate with clinical, project development, audit, regulatory, and commercial teams, as well as, external engineering partners to ensure alignment across the organization throughout device development activities and deliverables.
- Develop, foster relationship, and partners with the CPD Engineering Test & Analysis department in Ludwigshafen, Germany and California to ensure optimized use of resources and lab capabilities, as well as coordination of activities of both facilities.
- The Manager will ensure adherence to policy/procedures related to applicable standards, specifications, EHS, quality, and GMP manufacturing.
- A Bachelors Degree in Engineering, science, or closely related discipline or equivalent technical experience plus demonstrated competence. A post-graduate education/degree is desired, and may contribute towards the desired years of experience.
- 8+ years of significant engineering and/or operational experience.
- Has a career history marked by a consistent series of technical contributions and accomplishments. Significant contribution to product or process development or improvement through creative application of technical effort will equally be recognized.
- Possesses a strong technical knowledge and application of concepts, practices, and procedures. Works on problems of complex scope where analysis of situations or data involves multiple competing factors. Exercises judgment and advises management as to the appropriate actions.
- Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
- Listens to and understands others' points of view and articulates tactfully and respectfully one's own perspective orally, in writing, and in presentations.
- Works well with other engineers in a collaborative, fast-paced goal-driven environment.
- Possesses interpersonal skills to negotiate and reconcile differences.
- Has a technical background in health care, medical devices, pharmaceutical, biologics, or similar industries (preferred).
- Fluency in German language is a plus.
Significant Work Activities
Yes, 5 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.