Qualifications
- Ambitious and high performing with exceptional interpersonal and communication skills
- With the ability to influence behaviors, manage stakeholders, negotiate and resolve challenges with tact and diplomacy
- Experience in combination product (such as autoinjector, pre-filled syringe, wearable injector, pen injector, reconstitution device etc.), implants, ophthalmology and digital health is preferred
- Proven experience in launching of combination product through the entire development cycle in a CMC environment is highly desired
- Deep device design and development knowledge of first principles analysis, tolerance analysis, FEA, DOE, Design for Six Sigma (DFSS) and Design for Manufacturing (DFM) etc.
- Deep knowledge of the regulatory and compliance requirements of device/combination products design controls and manufacturing in US/EU/ROW. Experience with 510k, PMA, HDE, NDA, BLA, MDD, MDR is preferred
- Deep understanding of new product introduction, design and development of extruded, molded and/or assembled device products as well as testing and modeling methodologies
- Demonstrated good decision-making capability and driving alignment within matrix organization
- Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device vendor base. Ability to communicate and direct supplier activities at the management level
- Complex problem-solving skill and strong hands-on experience
- Experience of lead technical team and cross-functional project team. Ability to define and execute a project using project management techniques
- Proven results in meeting customer requirements and expectations
EDUCATION
- Bachelor’s Degree in Engineering required, Master’s Degree preferred
- 14+ years’ experience in medical device design and process development or related area
Additional Information
Biogen is seeking a qualified candidate for the role of device design and process development Senior III/Principal Engineer in the Medical Devices Department. The position will lead the design and development of patient-centric, safe, reliable, and innovative devices. Beginning with continuous research of cutting-edge technology to develop delivery systems integrated with the pipeline. Effectively and efficiently bring optimized products to market through rigorous science and engineering by leveraging external partnerships in collaboration with internal Human Factors, Packaging, Manufacturing Science, Engineering, Quality and Regulatory Affairs etc.