Our client is an early stage medical device company developing an innovative, elegant, and superior approach to the rapid cessation of bleeding.
Need a Development Engineer that has interest and qualifications to do technology development (focused more on customer need focused “R” (Research) than “D” (Development) and will lead biomaterial(s) based device development efforts.
Hands-on technical leader with broad based biomaterials expertise, provide engineering and project leadership in concept, feasibility, development, qualification and launch phases of device development.
Biomaterial and/or polymeric materials formulation expertise for development and characterization testing tools and techniques to develop bench top test methods and animal models that could be utilized for PDP
Experience in Voice of Customer for understanding clinical space and customer needs and translate those into technology requirements and product vision as well as execute concept development and feasibility assessments
Work closely with development team to convert technology concepts into products. Execute step-by-step product development (ensuring design quality and product performance requirements are met)
Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, preclinical studies and extensive collaboration with internal and external partners.
- Provide project and technical leadership on cross-functional team for devices through preclinical development, product registration and commercialization.
- Lead all project execution activities and oversee development of statistically sound design verification protocols/reports and design validation. Responsible for clear, concise, well written design history documentation, EU technical files, and manufacturing specifications.
- Establish maintain detailed project plans define risk and recommend contingency plans
- Lead the creation of design control elements to comply with medical device regulations to support the development of products in accordance Product Development Process and Design Control requirements as well as compliance with Good Manufacturing Practices (Quality Systems Regulations), Standard Operating Procedures, and Safety requirements.
- Establish and foster strong collaborative relationships with external design/development, manufacturing partners and service providers.
Our client is an early stage medical device company developing an innovative, elegant, and superior approach to the rapid cessation of bleeding. This is an opportunity to help a company grow.
- BS degree in Engineering required Master’s degree preferred.
- 6 + years medical device experience (especially with biomaterials based device or combination products) coupled with development and commercialization success.
- Technical leadership experience with biomaterials delivery system development and scale-up
- Strong hands on experience in injectable biomaterials based device design/development ideal
- Lead projects with external design, development and manufacturing partners
- Experience in developing and commercializing regulated devices / combination products under Design Control (21 CFR 820) and ISO13485 requirements, DFSS certification is desirable.
- Strong communication skills (written and verbal), including experience presenting in front of cross-functional audiences
- Must be able to multitask, handling a variety of projects simultaneously.