Lead Engineer, Cardiovascular Innovations

2 weeks ago

Eden Prairie, Minnesota, United States Collagen Solutions Full time

Company Overview

Collagen Solutions stands at the forefront of tissue-based biomaterials, dedicated to the supply and development of innovative solutions for regenerative medicine and medical devices. We are a dynamic and rapidly growing organization seeking talented individuals who share our vision:

To be the most trusted choice for medical biomaterial solutions

Our collaboration with leading structural heart organizations enables us to deliver exceptional contract development and manufacturing services for transcatheter heart valves, focusing on advanced tissue technologies that enhance valve performance and longevity.

Position Summary

The Lead Engineer plays a pivotal role within the Research and Development (R&D) team, spearheading both internal and contract product development initiatives. This position is essential for ensuring that innovative and high-quality products are produced efficiently while adhering to industry standards and regulations. The individual will be recognized as a leader within the organization, embodying our core values of teamwork, customer focus, accountability, and integrity.

Key Responsibilities

  • Lead new product development initiatives: conduct research, design, and obtain regulatory approvals for cutting-edge regenerative medicine products.
  • Collaborate actively with global cross-functional teams on product development projects.
  • Oversee Medical Device Design Control and Risk Management processes.
  • Manage projects effectively as required.
  • Plan, schedule, and coordinate project tasks and activities efficiently.
  • Employ structured problem-solving techniques to address design challenges during development.
  • Provide mentorship and guidance to team members.
  • Innovate new devices, techniques, and technologies utilizing material expertise and creative design.
  • Prepare documentation in line with relevant internal Standard Operating Procedures (SOPs).
  • Work closely with the product development team to define product development objectives while ensuring market alignment.
  • Enhance the company's intellectual property and patent portfolio through strategic research initiatives.
  • Engage with medical professionals regarding product design and application.
  • Draft engineering reports and presentations to communicate findings effectively.
  • Create prototypes and conduct necessary product testing.
  • Perform preclinical needs assessments.
  • Utilize 3D modeling software (e.g., Solidworks) proficiently.
  • Ensure compliance with regulatory and industry standards (FDA, MDD/MDR, ISO, ASTM, etc.) as applicable.
  • Support ongoing engineering efforts during process scale-up and manufacturing enhancement projects.
  • Contribute to the maintenance of compliance with the company's ISO 13485 Quality System.
  • Act as a technical team member for non-conformances, deviations, Corrective and Preventive Actions (CAPAs), and root cause analyses.
  • Stay informed about industry trends, emerging technologies, and best practices in biomedical engineering, tissue-related fields, and the structural heart market.
  • Maintain laboratory notebooks accurately.
  • Ensure a safe working environment.
  • Perform other duties as assigned by management.

Qualifications

  • Bachelor's degree in Material Science, Bioengineering, Chemistry, or a related technical field; advanced degree preferred.
  • Over 10 years of experience in medical device design and control.
  • Comprehensive knowledge of industry and market dynamics, particularly in collagen, tissue, and related biomaterials, as well as contract development and manufacturing.
  • Experience in tissue engineering and biomaterials is advantageous.
  • Proficiency in designing and testing cardiovascular implants, including transcatheter and surgical heart valves, covering:
    • Tissue selection
    • Leaflet design
    • Fabric integration
    • ISO 5840 testing
    • BDC and ViVitro testing equipment
    • Tissue fixation
    • Chemical sterilization

Knowledge & Skills

  • Project management experience is a plus.
  • Familiarity with laboratory prototyping, safety protocols, and handling hazardous materials.
  • Thorough understanding of the medical device industry and related disciplines.
  • Knowledge of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments.
  • Willingness to travel as necessary (less than 20%) within the US and internationally.
  • Exceptional organizational, communication (both verbal and written), and interpersonal skills.
  • Ability to work independently with minimal supervision.
  • Strong attention to detail, effective problem-solving, and decision-making capabilities.
  • Proficient in MS Project, Outlook, Excel, Word, and PowerPoint.

Job Description Intent

This job description is designed to assist organizations in ensuring a fair hiring process and selecting qualified candidates. It is also crucial for an effective appraisal system and related decisions regarding promotions, transfers, layoffs, and terminations.

All descriptions have been reviewed to ensure that only essential functions and basic duties are included. Peripheral tasks, only incidentally related to each position, have been excluded. Requirements, skills, and abilities included have been determined to be the minimal standards required to successfully perform the positions. Additional functions and requirements may be assigned by supervisors as deemed appropriate.

Job descriptions are not intended to create employment contracts. The organization maintains its status as an at-will employer, allowing for termination for any reason not prohibited by law.

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