About This Role

The Sr. Engineer III (Sr Manager) – Risk Management, will Lead and Develop the Risk Management of patient-centric, safe, reliable, and innovative medical devices and combination products, across various routes of administration such as SC, IM, IV, Intrathecal and Gene Therapy.

As an expert in Risk Management, the Risk Management Lead will provide subject matter expertise to cross-functional teams and guide Risk Management for medical devices and combination products across all modalities and across all clinical and commercial assets.  The position will drive key activities throughout all development phases of device and combination products, and facilitate the deliverables to support regulatory filings, product launches and post market surveillance requirements.

What You’ll Do

• Be regarded internally as the leading expert in medical device / combination product Risk Management.
• Author Risk Management deliverables for medical devices and combination products for multiple on-going programs, including electro-mechanical devices and/or Software as Medical Device (SaMD).
• Assist with project planning regards Risk Management activities and lead cross-functional meetings that include stakeholders in Risk Management deliverables – External Partners, Device Design, Human Factors, Clinical Development, GSRS, QA, Reg-Device, MS, Clinical Ops, etc.
• Review and approves all Design Control deliverables for multiple on-going projects.
• Provide SME input and guidance on Risk Management to cross-functional teams, across all stages of development and commercialization, across all modalities
• Author regulatory filings and address regulatory inquiries related to risk management.
• Liaise with department leadership and stakeholders to develop and implement roadmap for risk management for medical devices and combination products.
• Coach and mentor talents, raise awareness and improve institutional knowledge for risk management for medical devices and combination products.

Who You Are

You are an ambitious leader with exceptional interpersonal and communication skills, with an ability to communicate across all levels of the organization. You enjoy working on a variety of challenging projects, in a fast-paced environment, whilst providing leadership in complex situations. You have a strong people focus with a collaborative mind set and enjoys leading and potentially bringing a team to its full potential.

If this resonates to you we look forward to get your application.

Required Skills

• Bachelor’s Degree in Engineering or relevant scientific or technical discipline
• 7+ years of experience in Design Control and Risk Management related areas.
• Knowledge of the regulatory and compliance requirements of device design controls, risk management, human factors (i.e., ISO 14971, 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.
• Previous leadership experience

Preferred Skills

• Master’s Degree preferred
• Experience with risk management of electro-mechanical devices and/or SaMD

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

The base compensation range for this role is $110,900 to $178,800. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions.