Project Engineer - Biomedical (Adipose)

Position Title: Project Engineer - Biomedical (Adipose)
Department: Product Development
Reports To: Head of Product Development
Job Type: Full Time
Shift: Monday - Friday 08:30 AM - 05:00 PM
Exempt / Non-Exempt: Exempt

Purpose

The Project Engineer will support existing and new products with project management and development. This will include product management, prototyping, testing, and marketing associated with products.

 

Responsibilities

  • Manage and execute product development projects from ideation to market launch.
  • Lead project management activities on assigned projects including schedule, budget, work products and
  • Execute projects following design control practices and developing the necessary project inputs and outputs required for each development phase.
  • Organize appropriate methods of communication between project stakeholders.
  • Collect, organize, and communicate customer and market feedback to identify critical product characteristics.
  • Develop scalable and repeatable manufacturing processes for new products in collaboration with the Quality Assurance (QA) and Operations departments.
  • Author and revise standard operating procedures (SOP) according to FDA, AATB, and other regulations if applicable.
  • Review, analyze, and characterize critical financial characteristics of products including COGS.
  • Conduct group trainings for new processes and complete technology transfer of new products.
  • Perform processing of human tissue as part of the development of new processes.
  • Design and execute scientific experiments for product development projects. Complete data collection, evaluation, and interpretation of results to generate statistically significant data to support project decisions and/or product launch.
  • Specify, order, evaluate, and onboard new proprietary equipment in support of products.
  • Execute and plan new company initiatives including equipment onboarding, supply chain management, distribution capability, and product support.
  • Design and develop custom manufacturing equipment if applicable.
  • Support and expand existing product lines by responding to business development needs, collecting, and organizing product feedback, and improving and supporting products.
  • Support the development and implementation of sales material for products and work with Quality Assurance to ensure all claims are appropriate for market and regulatory position.
  • Conduct literature reviews to support new and existing products.
  • Assist with investigation of product quality events and appropriate preventive/corrective actions.
  • Support regulatory and reimbursement submissions for products.
  • Develop and execute validation protocols in accordance with regulatory Review validation data and draft validation reports.
  • Identify and develop a working knowledge of ASTM, AAMI, ISO, and other necessary validation or testing guidance’s required for assigned product development projects.
  • Develop working knowledge of FDA, AATB, and other regulatory requirements if applicable.
  • Perform other duties as assigned.
  • Maintain acceptable attendance and punctuality for scheduled work hours and meetings. Ensure completion of assigned tasks and responsibilities within defined timeframes.
  • Flexibility to work outside of normal business hours during weekdays or weekends with reasonable advance notice, to support business/operational needs when necessary.
  • Complete required hours on assigned duties works shift to complete assigned responsibilities and duties.

 

Skills

  • Project Management experience.
  • Ability to present complex ideas.
  • Technical writing ability.
  • Knowledge of manufacturing environment and validation procedures.
  • Strong analytical and creative thinking skills.
  • Ability to work in a fast-paced environment.
  • Ability to work independently and in a team environment.
  • Proficient in Microsoft Office.
  • Experience working with vendors and suppliers.
  • Ability to secure and maintain a favorable background investigation and clearance.

 

Qualifications/Requirements

  • Bachelor’s degree in biomedical or mechanical engineering or related field required.
  • 3 years of experience in project management required.
  • Experience with Mechanical Design.
  • Experience with CAD Software.
  • Education in Engineering, or Biological Science or related field preferred.
  • Product Development and exposure to medical products preferred.
  • Experience with allografts and/or medical devices preferred.