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Senior Research & Development Engineer

Class III Bioresorbable Scaffold: Peripheral Arterial Disease Intervention

Product Design & Development | Verification & Validation | Design Transfer

Join a pioneering company committed to transforming vascular intervention with a cutting-edge bioresorbable scaffold designed to enhance treatment for below-the-knee peripheral arterial disease (PAD). This innovative platform features a unique sirolimus coating and employs an ultra-high molecular weight polylactic acid polymer, striking the perfect balance between durability and flexibility-representing a significant advancement over traditional metal drug-eluting stents.

This exciting technology offers a promising alternative to below-the-knee amputation and is poised to significantly impact the over $2.5 billion U.S. PAD market.

We are seeking a Senior Research & Development Engineer who will be pivotal in developing and supporting both new and existing technologies and processes. This role is essential for technical leadership and innovation throughout the product lifecycle.

Our organization has recently secured significant financing that ensures you will have the needed resources to excel in this role.

Key Responsibilities:

  • Product & Process Development
  • Conceptualize and prototype new and existing products and manufacturing processes.
  • Engage with key opinion leaders (KOLs), clinicians, and staff to conduct user needs assessments.
  • Create comprehensive specifications, CAD models, and detailed drawings for products and assemblies.
  • Oversee parts suppliers or contract manufacturers to ensure compliance with specifications.
  • Leadership and Management
  • Guide and mentor engineering teams while providing essential training to technicians.
  • Organize and drive development and improvement projects to completion.
  • Stay informed about clinical and technical knowledge pertaining to products and competing technologies.
  • Validation and Verification
  • Conduct thorough validation and verification of device designs and manufacturing processes through scientific testing.
  • Write and execute test protocols, reporting on validation and verification activities.
  • Lead risk assessments and phase reviews for both new and existing devices and processes.
  • Respond effectively to complaints, ensuring prompt device or process investigations.
  • Participate in pre-clinical and clinical evaluations of device performance.
  • Manufacturing Knowledge Transfer and Training
  • Document and maintain manufacturing and testing processes to ensure consistency.
  • Support and train Operations staff on executing manufacturing and testing instructions.
  • Monitor process output, address root cause issues, and enhance process effectiveness.
  • Administrative Duties
  • Provide technical support for clinical operations by detailing device specifications and participating in clinical case planning.
  • Assist in overseeing device production and inventory management, including shipments and returns.
  • Communication
  • Maintain open and effective communication with cross-functional team members and leadership.

Qualifications:

  • Educational Background
  • Bachelor's degree in engineering or a related field.
  • Exceptional interpersonal and written communication capabilities.
  • Professional Experience
  • At least 5 years of experience in medical device development and manufacturing.
  • Strong background in the medical device sector with knowledge of regulated environments.
  • Proficiency in anatomy, physiology, and the patient care pathway.
  • Experience with stents, catheters, and peripheral vascular interventions is highly preferred.
  • Familiarity with IDE/PMA/regulatory processes involving catheters, stents, and drug delivery devices.
  • Solid understanding of scientific and engineering principles, including materials science and mechanics.
  • Hands-on experience with the complete product development lifecycle from concept through prototype and to manufacturing.
  • Expertise in packaging, sterilization, and V&V protocol/testing.
  • Familiarity with CAD/CAM/FEA, machining, and rapid prototyping techniques.
  • Extensive knowledge of preclinical and clinical operations.
  • Experience managing prototyping and manufacturing schedules and staff.

Read the full job description and apply online on the recuiter's web-site

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