Job Description
Job DescriptionSalary:
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 deliverables
- 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 preventative/corrective actions
- Support regulatory and reimbursement submissions for products
- Develop and execute validation protocols in accordance with regulatory requirements. 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
- Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures
- Travel domestically up to 5% to attend offsite meetings, conferences, and support business initiatives
- 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
- Perform other duties as assigned
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
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 preferred
- Experience with CAD Software preferred
- 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
- Clearance of favorable background investigation required