Field Clinical Engineer

Biogen; United States; Vor Ort; USD 131.000 - 175.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, Vision insurances

401(k) with match

Tuition reimbursement

Zusammenfassung

Biogen is seeking a Field Clinical Engineer to support the deployment of Class III implantable medical devices within the Implantable Device Unit. You will serve as a liaison among healthcare providers, Clinical Scientists, and internal teams, delivering real-time technical support and clinical education during procedures.

You will educate physicians and staff on device functionality, conduct trainings, collect clinical data, and ensure regulatory compliance across FDA/ISO guidelines.

Qualifikationen

• Bachelor's degree in Biomedical Engineering, Nursing, Life Sciences or related field.
• At least 7 years of experience in a clinical or field support role for implantable medical devices.
• Demonstrated experience providing field support for intrathecal device use during clinical procedures.
• Experience working in compliance with clinical trial regulations, SOPs and study protocols.

Aufgaben

• Provide on-site support during implantation and follow-up procedures involving Class III medical devices.
• Troubleshoot technical issues during procedures and provide immediate clinically sound recommendations.
• Act as the subject matter expert on device function and clinical applications.
• Educate physicians, nurses and allied health professionals on device functionality and workflows.
• Conduct in-service trainings, workshops and ongoing clinical education for new and existing users.
• Support collection of clinical data and user feedback for regulatory submissions and product development.
• Document field interactions in compliance with quality and regulatory standards.
• Collaborate with R&D, Regulatory, Safety, and Commercial teams to relay device deficiencies and clinical insights.
• Assist with investigational device trials, product evaluations and site initiation visits.
• Ensure activities comply with FDA, ISO 13485, MDR and company policies.

Kenntnisse

Clinical field support

Intrathecal device experience

Regulatory compliance

Ausbildung

Bachelor's degree in Biomedical Engineering, Nursing, or Life Sciences

MS or PhD (preferred)

Jobbeschreibung

About This Role:

As a Field Clinical Engineer, you will be an integral part of the Product Delivery Solutions team in the Implantable Device Unit, working closely with our Clinical Scientists. Your primary focus will be to support the clinical use and deployment of our advanced Class III medical devices, ensuring their successful integration into healthcare settings. You will act as a key liaison between our company, healthcare professionals, and various internal teams, providing real-time technical support during procedures and facilitating clinical education. Your role will be crucial in gathering field insights to drive product development and post-market surveillance, ultimately enhancing patient care and advancing our technological innovations. This position offers the opportunity to collaborate across multiple departments, contributing significantly to the refinement and success of our cutting-edge medical solutions.

What You’ll Do:

• Provide on-site support during implantation and follow-up procedures involving Class III medical devices.
• Troubleshoot technical issues during procedures and provide immediate, clinically sound recommendations.
• Act as the subject matter expert on device function and clinical applications.
• Educate physicians, nurses, and allied health professionals on device functionality, therapy benefits, and procedural workflows.
• Conduct in-service trainings, workshops, and ongoing clinical education for new and existing users.
• Support collection of clinical data and user feedback to assist with regulatory submissions, product development, and continuous improvement efforts.
• Document field interactions in compliance with quality and regulatory standards.
• Collaborate with R&D, Regulatory, Safety, and Commercial teams to relay device deficiencies and clinical insights.
• Assist with investigational device trials, product evaluations, and site initiation visits.
• Ensure all activities are performed in accordance with company policies, local regulations, and international standards (e.g., FDA, ISO 13485, MDR).

Who You Are:

You possess a deep understanding of clinical environments and have the ability to navigate complex procedures with ease. Your communication skills are exceptional, allowing you to educate and engage healthcare professionals effectively. You are adaptable, capable of prioritizing urgent site needs while maintaining strong internal stakeholder relationships. Your analytical mindset helps you provide insightful feedback and solutions, contributing to product advancements. You thrive in dynamic settings and are passionate about improving patient outcomes through innovative medical technologies.

Required Skills:

• Bachelor's degree in Biomedical Engineering, Nursing, Life Sciences, or a related field.
• At least 7 years of experience in a clinical or field support role for implantable medical devices.
• Demonstrated experience providing field support for intrathecal device use during clinical procedures.
• Experience working in compliance with clinical trial regulations, SOPs, and study protocols.

Preferred Skills:

• Advanced degree (MS, PhD) or clinical credentials.

Job Level: Management

Additional Information

Compensation

• The base compensation range for this role is: $131,000.00-$175,250.00
• 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.

Benefits

• 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 expandin