Biogen Sr Engineer III, Project Lead - Device Design and Development in Cambridge, Massachusetts
This position will lead the execution of medical devices and packaging development projects, ranging from various route of administration (SC, IM, IV, Intrathecal) while supporting patient-centric, safe, reliable and innovative devices, digital devices and packaging technology projects. The project lead will ensure alignment to the drug pipeline and execute, communicate deliverables and plans with internal stakeholders and external partners for Biogen.
The position will lead cross functional teams to drive key activities throughout development phases of device and combination products, including the deliverables to support regulatory filing, product launch and post market surveillance.
The Project Lead will lead Biogen’s cross functional Combination & PMA Device Development efforts specific to prefilled syringes, auto-injectors, pens, on-body injectors, transdermal, delivery to CNS and packaging solutions.
The ideal candidate will be an experienced project lead that can effectively and efficiently bring optimized products to market by leveraging external partnerships in collaboration with internal Technical Design, Human Factors, Packaging, Manufacturing Science, Engineering, Quality and Regulatory Affairs etc.
The candidate is considered a device subject matter expert (SME), and will provide project and engineering leadership in device/packaging and/or system identification, feasibility, development, qualification, launch readiness and commercialization for delivery systems and packaging.
Area of focus will be on leading a development team and where needed providing guidance regarding identification of user needs, product requirements and specification development, feasibility test development, design verification and validation testing, human factors, risk assessments, DHF creation, general project team support, and extensive collaboration with both internal stakeholders and external development partners.
Utilizes effective and efficient project management tools and best practices to deliver project goals.
Identifies applications of functional knowledge and existing methodologies to lead teams to solve complex problems; provides advice on a wide range of issues within area of subject matter expertise.
Liaise with third parties such as specialist manufacturers, design consultants and contractors.
Lead device and packaging selection and liaison with cross functional stakeholders in Early and Late stage development and LCM projects.
Manage key interfaces between line functions in manufacturing, quality assurance, supply chain, manufacturing and regulatory to progress device and packaging deliverables.
Identify multiple solutions and recommend a course of action to leadership; make complex decisions and troubleshoot in ambiguous situations.
Develop relationships with other groups. Communicates difficult concepts and negotiates with others to adopt a different point of view; Presents supportive arguments for complex ideas and projects to internal governance bodies and external stakeholders in a way that persuades them to adopt a different point of view, when appropriate.
Plays critical role in facilitating authoring of regulatory filings, and subject matter support and participation for global regulatory inquiries, requests and communications. Participates in face-to-face meeting with regulatory agencies.
Represent Biogen in industry discussion, and influence internally and externally.
Bachelor’s Degree in Engineering + 10-12 years of direct experience or Master’s degree with 8 - 10 years of direct experience.
Experience in design, development and commercialization of medical devices, packaging, project management, tooling, injection molding, extrusion, assembly, and production controls for assembly.
Deep understanding of new product introduction, design, and development of extruded, molded and/or assembled device products as well as testing and modeling methodologies.
Deep knowledge of the regulatory and compliance requirements of device design controls, risk management, human factors (i.e. FDA QSR 21 CFR 820 / ISO13485 quality system requirements, ISO 11608, and other relevant global standards).
Experience developing multiple device and combination product device products from research through registration and launch.
Strong communication, collaboration and team building skills; ability to connect with all levels of the organization.
Comfortable working in a matrix environment, while embracing and driving change.
Proven track record of developing and gaining regulatory approval of drug delivery systems a plus.
Oversee the project execution in compliance with design control SOP.
Oversee all aspects of the development process including pertinent DHF deliverables.
Manages stakeholders through excellent communications
Complex problem-solving skill and strong hands-on experience
Proven results in meeting customer requirements and expectations.
All your information will be kept confidential according to EEO guidelines.