AbbVie Senior Engineer, Devices and Combination Products in Lake County, Illinois
AbbVie (NYSE:ABBV) is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories . The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. AbbVie employs approximately 30,000 people worldwide and markets medicines in more than 170 countries.
The Senior Engineer, Devices and Combination Products, position has global responsibility for providing reliable, safe, and efficient product, specification, technology transfer and on market support of AbbVie’s pipeline products and commercialized products. The Senior Engineer is responsible for developing and implementing manufacturing strategy to assure consistent product knowledge and device compliance for the new product introduction and post market surveillance of the key devices and combination products. This role will also interact with Global Operations, R&D, Supply Chain, Quality, Regulatory, and Manufacturing Site to capture and exchange drug delivery devices and combination products knowledge across functional groups and geographical regions. The Senior Engineer, Devices & Combination Products, is the key point of contact within Global Operations Science & Technology for device manufacturing process topics including devices userability, combination product requirements, commercial specifications, design history files and change control.
Key Responsibilities Include:
- Master Devices & Combination Product Knowledge and provide the technical leadership to guide the new products design for manufacturing to the next level of reliability, pro-active performance, and compliant practices.
- Support post approval regulatory submission for market expansion and timely technical responses to FDA and global healthcare authority inquiries.
- Fulfill medical devices quality requirements – assist manufacturing site to build unique device identifier to comply with FDA’s UDI requirement.
- Establish technical relationship with strategic devices suppliers and attend due-diligence trips to evaluate potential devices suppliers.
- Lead device design transfer, maintain DHF (Design History Files), update DMR (Device Master Records), conduct post market human factor studies when necessary, and manage post approval device changes; oversee the implementation of design control training programs for the devices & combination products.
- Collaborate with R&D, supply chain, and commercial team to develop drug delivery devices for pipeline products and to provide post launch market support globally.
- Provide audit and pre-approval inspection support at the manufacturing sites to ensure consistent practices globally.
- Develop key performance measures for devices and combination products, monitor process control and report statistical analyses and summarize in presentations to drive product improvements.
- Champion technical innovations as subject matter experts in devices and combination product to internal stakeholders and external professional organizations.
- Develop systems and tools for design/devices change control in order to triage those changes which require regulatory submission as post approval supplement (PAS) in contrast to those changes which will not need regulatory submission.
- Lead technical aspects of product design change to support quality closures.
- Assess new and existing ISO standards for medical devices and combination products to ensure regulatory compliance and maintain license to operate.
- Engage medical affairs, supply chain, quality, regulatory, packaging and R&D teams to gather and incorporate inputs for managing on-market product changes.
- Solve product defects and supply issues by identifying root causes using six sigma methodologies.
- Prepare technical files and update documents including product specifications, DHF, drawings, bill of materials, study protocols and engineering confidence test reports.
- Use statistical analysis to evaluate raw data acquired through verification and validation study results.
- Expected to work on a regular basis with each region, e.g., early and late conference calls
- Travel estimated at 10% of time, including some global travel. Equal Opportunity Employer Minorities/Women/Veterans/Disabled
* * Basic:
- A Bachelor Degree in Engineering, Chemical, Mechanical, Biomedical, Electronics, and /or Materials Sciences, plus demonstrated competence. Advanced degree is desired and may contribute towards the years of experiences.
- Multiple years of Technical experience with Pharmaceutical/Biotech sectors with technical background in health care, medical devices, biological, or pharmaceutical companies is preferred.
- Consistently demonstrated competency with design control, change management and technology transfer processes.
- Multiple years of devices and combination product testing and issue investigation for root cause analysis.
- Experience in leading virtual teams and roll-out of regional or global initiatives.
- A career history marked by a consistent series of significant contributions and accomplishments.
- Demonstrated and been recognized for excellence in breadth and depth of device knowledge in global projects.
- Interacts well with diverse groups across corporation 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.
- Possess interpersonal skills to negotiate and reconcile differences, while optimizing overall organizational goals.
Capacity and Willingness to learn and grow in science and technology fields.
- * Key Stakeholders
Global Research & Development
- Global Quality
- Global Regulatory Affairs
- Global Supply Chain
- Global Engineering
- Global Medical Affairs
Global Commercial Team
- * Knowledge, Skills, And Abilities
- Expertise in pharmaceutical/biotechnology operational best practices and regulatory expectations.
- Demonstrated subject matter expertise in devices and combination products
- Specialize in design for manufacturing
- Excellent communication skills: technical with business acumen
- Familiar with drug delivery devices market landscape and competitive Intelligence
Job Classification: Experienced
Job: RESEARCH AND DEVELOPMENT
Primary Location: USA-Illinois-Lake County
Travel: Yes, 10 % of the Time
Req ID: 1705200
Equal Opportunity Employer Minorities/Women/Veterans/Disabled