Senior Product Development Engineer/Scientist

Birmingham, AL

Job Req code: 1082

Category: Research & Development

We have unique opportunities and are always looking for exceptional talent. Join a company where you will have an opportunity to grow professionally and personally and give strength to others by Empowering Healing.

Under the supervision of the Assistant Director of Product Development, the Senior Product Development Engineer/Scientist will assist in the development and execution of the Company’s overall product development plan. In this role, the candidate will lead cross functional product development projects critical to the company. Critical activities of this role include planning, managing projects to plan and budget, and designing and executing required testing to support state of the art products/technologies for a number of regulatory paths (e.g., 510K, HCT/P, PMA, and BLA). Primary responsibilities include: 

  • Serve as technical leader of cross functional product development teams.
  • Work with marketing and commercial teams to develop market assessments, project charters and product requirements.  
  • Execute design activities in compliance with Design Control and in accordance to applicable regulations.
  • Mentor junior members of team, as needed.
  • Assist in development of overall direction product development efforts.
  • Deliver on projects on time and effectively prioritize based on company’s objectives.
  • Independently plan and execute required biocompatibility studies, characterization testing and performance testing.
  • Analyze data and compose results into reports or peer reviewed formats, as required.
  • Participate in and contribute to product development & research meetings.
  • Assist in ensuring laboratory suitability by assisting in developing and maintaining necessary procedures for complying with laboratory safety standards. 
  • Comply with all safety and infection control standards.
  • On occasion you will travel to attend relevant scientific meetings or to meet with collaborators.

Requirements

  • M.S. or Ph.D. in Biomedical Engineering, Biologic Engineering, Cell Biology or similar field of study.
  • 5+ years of industry experience working in Product Development and knowledge of design controls.
  • Experience working in cross functional environment.
  • Proficient computer skills including Microsoft Office (Work, Excel, PowerPoint, Project).
  • Excellent communication skills.

PREFERRED QUALIFICATIONS:

  • Product development experience with 510Ks or HCT/Ps.
  • Knowledge of wound healing.

SUPERVISION RECEIVED:

Under the supervision of the Director, Product Development.

SUPERVISION EXERCISED:

No

ENVIRONMENTAL WORKING CONDITIONS:

Wet biological laboratory, and may require appropriate contact with biohazards, animals and human specimens.

Organogenesis is committed to being an equal opportunity and affirmative action employer and recognizes the power of a diverse community. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or protected veteran status.