SENIOR PRODUCT ENGINEER
Dimension Inx, based on research from former Northwestern Prof. Ramille Shah's lab, is creating next-generation biomaterials and 3D-printed bioactive structures that enable organ and tissue regeneration and repair
The Senior Project Engineer will report directly to the Chief Scientific Officer. They will have a direct role in creating a new portfolio of solutions that heal and restore people’s lives through Dimension Inx’s regenerative biomaterials platform. They will play a key role in new product development, working closely with the product management team.
The ideal candidate brings a strong technical background in tissue engineering and biomaterials, plus industry experience leading projects from concept through market introduction. This person thrives in a rapid, multi-tasking startup environment and is ready to roll up their sleeves and jump into the deep end of the emerging world of advanced biomaterials and biofabrication. This is an opportunity for someone who wants to be among the first members of a highly driven team with big ambitions and offers the potential to grow in a challenging, engaging, and entrepreneurial environment.
Please send your CV/resume to firstname.lastname@example.org.
- Lead and execute multiple projects in the development and evaluation of regenerative medical products, including preparing and optimizing product development timelines and budgets
- Lead engineering and product evaluation from initial concept and design through prototyping, design controls, manufacturing, regulatory approval, and market introduction
- Design scalable, quality-controlled processes for biomaterials synthesis, 3D-printing/additive manufacturing, 3D culture systems, and generation of tissue engineered products
- Develop and execute protocols for product validation and verification, managing external relationships with contract research organizations as needed
- Document data and communicate results through technical reports as well as appropriate maintenance of DHFs, DMRs, and DHRs
- Work closely with the product management team to support project kick-off meetings and design reviews
- Build and manage lab operations and the engineering team, including developing additional capabilities as needed and maintaining a safe and compliant environment
- Advanced degree (Ph.D. or Master’s) in biomedical engineering, tissue engineering, biomaterials science, or similar field
- Minimum 7 years of experience in a MedTech or Pharma/Biotech product focused organization, leading projects from engineering design through production
- Hands-on laboratory experience with cell/biomaterial interactions, cell culture, tissue processing, and assays to support materials and tissue characterization – 3D-printing experience is a plus
- Ability to maintain compliance with quality management systems and controls, specifically ISO 13485 and FDA 21 CFR 820 requirements
- Demonstrated proficiency in project management and experience developing products within a stage gate process
- Excellent communication (written, oral, visual) and organizational skills, and strong business acumen
- Exceptional levels of intellectual capacity and curiosity, creativity in problem-solving, perseverance and self-initiative, and entrepreneurial drive
CONTACT: Matt Opad (email@example.com)
posted May 25, 2021