|Position Title:||Project Engineer|
|Reports To:||Director of Product Management|
|Job Type:||Full Time|
|Shift:||Monday - Friday 08:00 AM - 05:00 PM|
|Exempt / Non-Exempt:||Exempt|
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.
Duties & Responsibilities:
- Execute new product development projects as additions to the company portfolio in conjunction with Technology, Quality Assurance, and Operations departments.
- Collect, organize, and communicate customer and market feedback to identify critical product characteristics.
- Assist development of manufacturing processes with focus on repeatability and practicality.
- Revise procedures according to FDA, AATB, and other regulations (as appropriate).
- Review, analyze, and characterize critical financial characteristics of products including COGS.
- Assist with training and technology transfer for new products.
- Perform processing of human tissue as part of the development of new processes.
- Specify, order, evaluate, and onboard new proprietary equipment in support of products.
- Lead project management activities on assigned projects including schedule, budget, work products and deliverables.
- Follow projects from initiation to completion working with multidepartment teams.
- Execute, and assist planning of new company initiatives including equipment onboarding, supply chain management, distribution capability, and product support.
- Collaborate with department teams to establish and support project timelines.
- Organize appropriate methods of communication between project stakeholders.
- 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.
- Support existing and new products with literature review and summarization.
- Assist with investigation of product quality events and appropriate preventive/corrective actions.
- Support regulatory and reimbursement submissions for products.
- Assist design and performance of validation protocols in accordance with regulatory requirements.
- Develop working knowledge of FDA, AATB, and ISO regulatory requirements.
- Perform other related duties as assigned.
Skills & Abilities:
- 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.
Education & Experience:
- Bachelor’s degree in related field and education in Project Management required.
- Education in Engineering, or Biological Science or related field preferred.
- Minimum 12 months experience in managing project(s) from start to finish required.
- Product Development and exposure to medical products preferred.
- Experience with allografts and/or medical devices preferred.