Field Clinical Engineer

atBiogenRemoteUS flagUnited StatesFull-timeEngineerSeniorLead$131k – $175.3k/year

Posted 3 days ago

This is a fully remote position, open to applicants in United States.

πŸ“‹ Description

β€’ Assist in the clinical application and implementation of Class III medical devices.

β€’ Provide on-site assistance during implantation and follow-up procedures.

β€’ Diagnose technical challenges during procedures and offer immediate clinical advice.

β€’ Act as the subject matter expert regarding device functionality and clinical applications.

β€’ Train physicians, nurses, and allied health professionals on device operation, therapeutic advantages, and procedural workflows.

β€’ Conduct in-service training sessions, workshops, and ongoing clinical education.

β€’ Gather clinical data and user feedback for regulatory submissions, product development, and continuous enhancement.

β€’ Record field interactions in accordance with quality and regulatory standards.

β€’ Collaborate with R&D, Regulatory, Safety, and Commercial teams to communicate device shortcomings and clinical insights.

β€’ Support investigational device trials, product assessments, and site initiation visits.

β€’ Ensure all activities adhere to company policies, local regulations, FDA, ISO 13485, and MDR standards.


⛳️ Requirements

β€’ A Bachelor’s degree in Biomedical Engineering, Nursing, Life Sciences, or a related discipline.

β€’ A minimum of 7 years of experience in a clinical or field support role for implantable medical devices.

β€’ Proven experience providing field support for intrathecal device usage during clinical procedures.

β€’ Familiarity with compliance standards related to clinical trial regulations, SOPs, and study protocols.

β€’ Capability to navigate complex clinical procedures effectively.

β€’ Outstanding communication skills for educating and engaging healthcare professionals.

β€’ Ability to prioritize urgent needs at sites while maintaining relationships with internal stakeholders.

β€’ Analytical mindset for delivering feedback and solutions.

β€’ Preferred: An advanced degree (MS, PhD) or clinical credentials.

β€’ Must adhere to company policies, local regulations, and international standards, including FDA, ISO 13485, and MDR.


🏝️ Benefits

β€’ Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.

β€’ Comprehensive Medical, Dental, Vision, and Life insurance coverage.

β€’ Fitness and Wellness programs, including reimbursement for fitness expenses.

β€’ Short- and Long-Term Disability insurance coverage.

β€’ A minimum of 15 days of paid vacation annually.

β€’ Additional paid time off at the end of the year (Dec 26-Dec 31).

β€’ Up to 12 company-paid holidays.

β€’ 3 paid days off for Personal Significance.

β€’ 80 hours of sick leave per calendar year.

β€’ Paid Maternity and Parental Leave benefits.

β€’ Participation in a 401(k) program with company-matched contributions.

β€’ Employee stock purchase plan.

β€’ Tuition reimbursement up to $10,000 per calendar year.

β€’ Opportunities to participate in Employee Resource Groups.

β€’ Continuous learning, growth, and opportunities to enhance skills.

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