Principal Engineer, Structural Heart

2 weeks ago

Eden Prairie MN United States Collagen Solutions Full time

"Collagen Solutions is a global leader in tissue-based biomaterials supply and development for use in regenerative medicine and medical devices. We are an exciting fast-paced growth company looking for high caliber team members passionate about our vision:



To be the most trusted choice for medical biomaterial solutions


We work with leading structural heart companies to provide best-in-class contract development and manufacturing of transcatheter heart valves. Specializing in advanced tissue technologies to extend valve durability and enhance valve hemodynamics.



The Principal Engineer works within the R&D department to drive internal & contract product development & research programs. This position is a key role within the R&D organization ensuring innovative and quality products are delivered in a timely manner while maintaining compliance with industry standards and regulations. They will be seen as a recognized leader while exhibiting the company’s values of teamwork, customer focus, accountability, and integrity."


ESSENTIAL FUNCTIONS AND RESPONSIBILITIES


  • Champion new product development projects: researching, developing, and securing regulatory approval for new regenerative medicine products.
  • Actively engage and collaborate on global cross functional product development teams.
  • Medical Device Design Control and Risk Management.
  • Project management as necessary.
  • Plan, schedule and coordinate project tasks and activities.
  • Utilize structured problem-solving approaches to resolve design investigations during development.
  • Provide mentorship.
  • Conceptualize new devices, techniques, and technologies using material knowledge and innovative design.
  • Prepare documentation in accordance with relevant internal SOPs.
  • Work closely with product development team to establish product development goals while ensuring market compatibility.
  • Grow the company’s IP & patent portfolio through strategic internal research.
  • Ability to interface with physicians on product design and use.
  • Author engineering reports and presentations as required to document and communicate results.
  • Create prototypes and conduct product testing, as necessary.
  • Performs preclinical needs assessments.
  • Experience with 3D modeling software (e.g. – Solidworks).
  • Ensure compliance with regulatory and industry standards (FDA, MDD/MDR, ISO, ASTM, etc.) as appropriate.
  • Support sustaining and process engineering efforts during process scale-up and manufacturing improvement initiatives.
  • Contribute to and maintain compliance with company’s ISO 13485 Quality System.
  • Technical team member for non-conformances, deviations, CAPAs, and root cause investigations.
  • Stay current with industry trends, emerging technologies, and best practices in biomedical engineering, tissue-related fields and structural heart market.
  • Maintain laboratory notebooks.
  • Maintain a safe work environment.
  • Other duties as reasonably assigned by the management team.


QUALIFICATIONS


  • Minimum bachelor's degree in Material Science, Bioengineering, Chemistry, or related technical discipline. Advanced degree preferred.
  • 10+ years of medical device and design control experience.
  • Extensive knowledge of the industry and market conditions, specifically collagen, tissue and other related biomaterials and contract development/manufacturing.
  • Experience in tissue engineering and biomaterials is a plus.
  • Experience designing and testing cardiovascular implants such as transcatheter and surgical heart valves including:
  • Tissue selection
  • Leaflet design
  • Fabric integration
  • ISO 5840 testing
  • BDC and ViVitro testing equipment
  • Tissue Fixation
  • Chemical Sterilization


KNOWLEDGE & SKILLS


  • Project management experience a plus.
  • Working knowledge of laboratory prototyping, safety precautions and protocols for safe handling and the disposal of hazardous agents, re-agents, chemicals, and materials.Thorough understanding of medical device industry. Working knowledge of other related disciplines.
  • Working knowledge of Design for Six Sigma, Risk Management techniques, Statistical Analysis methods, and Design of Experiments.
  • Ability to travel as needed (

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