Senior Engineer, Device Design and Development

Job Description

Biogen is seeking a qualified candidate for the role of device design and process development Senior II Engineer in the Medical Devices & Packaging Department.

The position will lead the design and development of patient-centric, safe, reliable, and innovative devices and combination products.

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, Project Management, Quality and Regulatory Affairs etc.

The position will lead the design and process development of medical devices and combination product projects, ranging from various route of administration (SC, IM, IV, Intrathecal) and supporting patient-centric, safe, reliable, and innovative devices, combination product and digital devices projects.

The technical lead will provide innovative and robust design and process solutions to enable Biogen drug delivery pipeline and enhance patient convenience.

The position may occasionally 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.

This is a hybrid role to be based at our headquarters in Cambridge, MA.

What You’ll Do

• Create innovative device / combination product / digital health solutions aligned to the drug pipeline. Identify multiple solutions and recommend a course of action to leadership;
• Make complex decisions and troubleshoot in ambiguous situations across the department; Creates an environment of experimentation;

works across disciplines / functions to test and advance innovative processes and methodologies.

• Optimize design for usability, design robustness and manufacturability. Applies technical, functional, and business knowledge to design experiments / projects that contribute to strategic direction of department / discipline / group.
• Create experimental plan, data, and reports. Develops and promotes the use of novel approaches within own area of expertise;

routinely investigates / creates innovative processes, hypotheses, and methodologies to solve unique and complex problems.

Assist with project planning including organizing experiments, staff, meetings. Engages in publishing internal and external documents, and presentation of own scientific work, as required;

Collaborates with others to expand business opportunities within the function / division.

Develop relationships with other groups. Communicates difficult concepts and negotiates with others to adopt a different point of view;

Presents supportive arguments for highly 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 write-up of regulatory filing and answering regulatory questions. Participates in face-to-face meeting with regulatory agencies.
• Liaise with third parties such as contract design and manufacturing companies, testing lab etc.

Who You Are

You are an ambitious and high performing individual with exceptional interpersonal and communication skills. You have the ability to influence behaviors, manage stakeholders, negotiate, and resolve challenges with tact and diplomacy.

You should have experience working in cross-functional teams performing high impact work and can define and execute project tasks using project management techniques with proven results in meeting customer requirements and expectations.

Qualifications

• Bachelor’s Degree in Engineering (Master’s Degree preferred) plus 6-8 years’ experience in medical device design and process development or related area.
• Deep knowledge of Design for Six Sigma (DFSS) and Design for Manufacturing (DFM)
• Deep knowledge of the regulatory and compliance requirements of device / combination products design controls and manufacturing in US / EU / ROW
• 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
• Proven results in meeting customer requirements and expectations.
• Ability to define and execute a project using project management techniques.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.

Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills.

Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply.

Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve.

We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.

Biogen is an E-Verify Employer in the United States.