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Development Engineer (medical device)

Natick, MA · Healthcare
  • $110,000 range + bonus, stock options, Comprehensive Benefit, and Retirement Programs 
  • This is direct hire role.
  • local candidates only


Our client is a medical device startup developing an innovative, sophisticated, and superior approach to the rapid cessation of bleeding. They need a Development Engineer that will lead bio-material based device development efforts. As a hands-on technical leader, you will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. Area of focus will include identification of user needs, specification development, prototyping, test development, design verification and validation testing, risk assessments, pre-clinical studies etc. Extensive collaboration with internal and external partners.

Responsibilities:
  • Provide project and technical leadership on cross-functional team for devices through pre-clinical development, product registration and commercialization.
  • Lead all project execution activities and oversee the 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.

 
Who Will Be a Great Fit?  
  • 5 + years medical device expertise coupled with development and commercialization success.
  • Strong hands on experience in injectable bio-materials based device design/development ideal
  • Technical leadership experience with bio-materials delivery system development and scale-up
  • Leading 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.


 
As recruiters, we are skilled in our field and understand how to match an opportunity with the individual. Be advised we will not distribute your resume outside our firm without first speaking with you and obtaining your permission.

Brian Hughes
Great Bay Staffing Group​
Professional Search & Contract Staffing
​603.834.9492 
Feel free to forward this job opening to qualified individuals!
or email to:
resumes at GreatBayStaffing.com
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