Senior Engineer II, Device Development

Qualifications

• Minimum Required Qualifications:
• Bachelor’s degree in biomedical, electrical, mechanical, or related engineering discipline with at least 6 years of experience in device and/or combination product development, including 3+ years of experience with drug delivery and combination products such as autoinjectors, pre-filled syringes, wearable injectors, pen injectors, or drug reconstitution devices.
• Experience working within medical device and combination product standards and regulations, including ISO 13485, ISO 14971, 21 CFR Part 4, 510(k), PMA, MDD, MDR, and other applicable US and EU regulatory expectations.
• Experience supporting new product introduction, including design, engineering analysis such as first-principles modeling and FEA, prototyping, development, and testing of extruded, molded, and/or assembled device products, as well as relevant testing and modeling methodologies.
• Preferred Qualifications:
• Advanced degree in biomedical, electrical, mechanical, or related engineering discipline.
• Experience with a requirements, risk management, tracebility software tool (e.g. JAMA DOORS, Polarion, CodeBeamer).
• Demonstrated enthusiasm for and fluency in artificial intelligence, with the ability to creatively integrate AI-enabled tools into day-to-day work to streamline workflows, improve productivity and quality, accelerate problem-solving, and identify new ways of working.
• Experience developing and launching a drug-device combination product, such as a prefilled syringe, autoinjector, wearable injector, pen injector, infusion system, or related delivery system, from concept through commercialization.
• Experience with research and development of electromechanical medical devices, handheld delivery systems, or connected drug delivery technologies.
• Knowledge of medical device mechanical engineering tools and frameworks, including Design of Experiments, Design for Six Sigma, and Design for Manufacturing, as well as regulatory and compliance requirements for device and combination product design controls and manufacturing in the US, EU, and other regions.
• Additional Information
• 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 bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
• 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 insurances
• Fitness & Wellness programs including a fitness reimbursement
• 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
• 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 Biogen.
• 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.