Product Development Engineer

Company: MiMedx
Location: Marietta
Posted on: January 15, 2022

Job Description:

At MiMedx, our purpose starts with helping patients heal. We are driven by discovering and developing regenerative biologics utilizing human placental tissue to provide breakthrough therapies addressing the unmet medical needs for patients across multiple areas of healthcare. Possessing a strong portfolio of industry leading advanced wound care products combined with a promising clinical pipeline, we are committed to making a transformative impact on the lives of patients we serve globally.

POSITION SUMMARY:
Lead product development projects in an effort to effectively launch new products, line extensions and/or process improvements. Responsible for assembling a cross-functional team, assigning deliverables and managing timelines. All activities will follow the defined product development process for the respective regulatory path, primarily 361 and 510(k).

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for managing the documentation of product development activities in concept, feasibility, development, verification and validation to design transfer.
Manage a cross functional team; hold regular meetings with core team and communicate progress with executive management
Develop and manage the project plan and deliverables to progress through the development process
Establish and maintain the design history file in support of regulatory filings
Work closely with outside consultants for regulatory, manufacturing and other advice regarding projects
EDUCATION/EXPERIENCE:
BS/BA in relevant discipline and 5-7 years of experience in related field, or verifiable ability
OR
MS/MA in relevant discipline and 4-5 years of experience in related field, or verifiable ability
OR
PhD in relevant discipline and 4-5 years of experience in related field
Required experience with project management
Required human cell and tissue/processing (HCT/P) and/or medical device experience
Required prior experience in regulated industry (i.e., GLP 21 CFR 58 and/or cGMP 21 CFR 210-211)
SKILLS/COMPETENCIES:
Excellent oral, written, and interpersonal communication and computer skills
Strong organizational skills with attention to detail and accuracy
Strong analytical and problem solving skills
Strong presentation skills; ability to successfully interact with all levels within the company
Proficient in organizational tools (Microsoft project, Visio, Excel)

Keywords: MiMedx, Marietta , Product Development Engineer, Engineering , Marietta, Georgia