Principal Engineer, Device Design and Development Technical Lead

Job Description

About This Role

Biogen is seeking a qualified candidate for the role of Principal Engineer, Technical Lead in the Device Development group. 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 multidisciplinary drug delivery systems to support Biogen’s drug product 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, Engineering, Quality, Regulatory Affairs, and other cross-functional stakeholders.

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

What You Will Do

• Design innovative drug delivery devices and combination products aligned to Biogen’s drug product pipeline. These products may range from the selection of pre-filled syringes to the design of implantable drug delivery systems.
• Identify multiple solutions and recommend a course of action to leadership. Make complex decisions and troubleshoot in ambiguous situations across the department. Create an environment of experimentation and work across disciplines and functions to advance novel drug delivery solutions.
• Optimize design for usability, design robustness, and manufacturability. Apply technical, functional, and business knowledge to design experiments and solutions that contribute to Biogen’s strategic priorities.
• Create experimental plans, analyze data, and write reports. Develop and promote the use of novel approaches within your area of expertise. Routinely investigate and create innovative solutions, hypotheses, and methodologies to solve unique and complex problems.
• Assist with project planning, including organizing experiments, staff, and meetings. Engages in publishing internal and external technical documents, and presentation of own scientific work, as required. Collaborates with external clinical experts and industry to expand business opportunities.
• Develop relationships with other groups. Communicate difficult technical concepts and influence others to appreciate a novel point of view. Present supportive arguments for complex ideas and projects to internal governance bodies and external stakeholders.
• Contribute to the writing of regulatory filings and answer regulatory questions. Participate in face-to-face meetings with regulatory agencies. Liaise with third parties such as contract design and manufacturing companies, testing labs, and other experts.
• Lead technical team and/or cross-functional project teams.

Who You Are

You are a highly motivated and results-oriented engineer with extensive hands-on experience, coupled with exceptional interpersonal and communication abilities. You are skilled in influencing stakeholders, negotiating effectively, and addressing challenges with diplomacy and tact. With proven experience in leading technical and cross-functional project teams, you thrive at defining and executing projects using project management methodologies, consistently delivering results that meet customer requirements and expectations.

Qualifications

Required Qualifications:

• Bachelor’s degree in engineering.
• 10+ years’ experience in medical device design, especially drug delivery systems.

• Demonstrated experience in combination products (such as autoinjectors, pre-filled syringes, wearable injectors, pen injectors, reconstitution devices, etc.)
• 5+ years' experience facilitating the interface between the pharmaceutical company and the medical device vendor base. Ability to communicate and direct supplier activities at the management level.

Preferred Qualifications:

• Advanced degree in Biomedical, Electrical, or Mechanical engineering, with 8+ years of experience in medical device design (Class II and Class III), preferably including the design of drug infusion pumps, catheters, and active and passive implantables.
• Proven experience developing and launching a drug combination product through the entire product development lifecycle.
• Deep device design and development knowledge of first principles analysis, tolerance analysis, FEA, DOE, Design for Six Sigma (DFSS), Design for Manufacturing (DFM), etc.
• Deep knowledge of the regulatory and compliance requirements of device/combination products design controls and manufacturing in the US, EU, and other regions. Experience with ISO 13485, ISO 14971, 510k, PMA, MDD, MDR.
• 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.

Additional Information

The base salary range for this position is $156,000-$215,000. Base salary offered is determined through an analytical approach utilizing a combination of factors, including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short-term and long-term incentives, including cash bonuses and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit, and company performance.

Benefits

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees and their families' physical, financial, emotional, and social well-being, including, but not limited to:

• Medical, Dental, Vision, & Life insurance
• Fitness & Wellness programs, including a fitness reimbursement
• On-site childcare facility in Cambridge, MA
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 paid days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company-matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

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. Read on 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.