Staff Product Development Engineer

Staff Engineer

Under Director oversight, the Staff Engineer will drive engineering duties associated with the design, research, development, and implementation of complex research and product development projects, to completion, in the regenerative medicine medical device space addressing unmet clinical needs.

Responsibilities include:

• Independently determines and develops approach to solutions.
• Represents the organization as the primary technical contact on projects. Interacts with senior internal or external personnel on significant technical matters requiring coordination between organizations.
• The employee must conduct their work activities in compliance with AbbVie internal requirements and applicable regulatory requirements, including 21 CFR 820, ISO 13485 and ISO 14971. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
• On-site, in-office and R&D laboratory presence.
• No expected direct supervisory responsibilities, but will lead a technical project sub-team or workstream(s) in the design and development of new products.

New Product Development:

• Typically serves as Product Development representative on cross-functional project teams within the Business Stage Gate Process; establishes technical strategies and defines tasks, deliverables, and timelines, budgets and resource needs with project sub-team and leads the execution of the established technical strategies with a focus on Early Stage Product Development.
• Partners with Marketing and cross-functional stakeholders to establish user requirements and translates them into clinically relevant technical requirements through research, experiments, and customer interactions.
• Applies product risk management (ISO 14971) to design inputs, design outputs, and risk control measures.
• Prepare for and lead formal Design Reviews in accordance with Design Control.
• Develops and/or applies physical and mathematical models in support of product design; develops experimental designs and protocols to demonstrate product feasibility; analyzes and resolves complex design problems associated with product performance.
• Designs products, including prototype development of devices, fabrication, prototype/sample testing and analysis; applies understanding of surgical and medical procedures, products and trends in related therapeutic area to product design.
• Designs novel test methods and testing fixtures and apparatus in support of technical strategies and readiness for design verification.
• Develops technical specifications to meet requirements; applies advanced engineering principles to the design, fabrication, testing and evaluation of products and when resolving technical challenges.
• Prepares and delivers technical and project presentations to internal and external customers, including senior management.
• Identifies outside vendors and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
• Leads technical reviews; reviews and approves the work of more junior engineers, scientists and lab associates.
• Coaches and mentors junior technical staff.
• SME for Design Control deliverables in audits.

Innovation & R&D Process Efficiency:

• Innovates by identifying, investigating, and evaluating existing technology.
• Designs and implements new methodologies, materials, machines, processes or products.
• Process and system improvements to facilitate efficient project execution.
• Executes against the overall strategy for the Plastics and Regenerative Medicine Franchise.

Qualifications:

• Bachelors Degree in engineering or related field with 9+ years Product Development experience, or Masters degree with 7+ years Product Development experience, or PhD with 4+ years Product Development experience required.
• Detailed understanding and wide application of technical principles, theories, and concepts in the field. General knowledge of other related disciplines.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical journals and governmental regulations. Ability to write reports, business correspondence, documentation and procedures.
• Ability to learn and function in a controlled environment regulated by FDA GMPs and handle confidential data.
• Medical device and/or combination product experience in a regulated environment.
• Experience developing products within a business stage gate process (preferred).
• Experience and expertise in user needs and development of technical requirements.
• Experience and expertise observing medical devices used in surgical and office-based clinical settings to inform development of use-case scenarios for application into User Needs, Technical Requirements, Human Factors, and Product Risk Management deliverables.
• Experience in medical device development for early stage clinical studies using medical devices, such as First-in-Human studies.
• Experience working in a laboratory environment.
• Ability to travel if needed, ~5-10% of time project dependent.

Other Professional Skills:

• Demonstrated critical thinking and problem solving skills
• Ability to exercise judgment both within defined procedures and policies and balanced across technical and business needs
• Ability to prioritize and manage concurrent projects.
• Ability to manage diverse, simultaneous projects of varying complexities
• Self-motivated; ability to execute under minimal supervision
• Identifies, understands and proactively mitigates technical/product risk
• Ability to communicate highly technical information in a clear and easy-to-understand way (both verbally and in writing)
• Demonstrated strong business acumen
• Team leadership experience
• Applied experience with statistical analysis; experience using Minitab preferred
• Demonstrated understanding of advanced engineering principles and practices
• Design Control and Product Risk Management knowledge
• Experience with complex experimental design
• Product development experience
• Experience using Computer-Aided Design (CAD) programs; Solidworks preferred
• Microsoft Office Suite including Word, Excel, PowerPoint, Visio, Project and Outlook