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.

Duties & 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
• 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 related duties as assigned.
• Report to work in-person and start job on time for established shift.
• Complete required hours on assigned duties works shift to complete assigned responsibilities and duties.

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.
• Ability to secure and maintain a favorable background investigation and clearance.

Education & Experience:

• 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, preferably SolidWorks’.
• Experience in medical device product development and manufacturing.
• Experience in FDA or AATB regulated field.
• Knowledge of Design Control procedures.