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:

• Experience developing sterile products
• Experience with CAD software (Solid works, fusion, AutoCAD)
• Experience with the process validation and sterilization validations
• Experience planning and drafting validation protocols and validation reports
• Experience with the validation of sterile barrier packaging systems
• Experience leading projects from the research phase to commercialization
• Design and development of manufacturing procedures
• Familiarity with ISO 13485, AATB, or risk management standards
• Experience with design control procedures
• Experience working in or with ISO classified cleanrooms
• Familiarity working with ASTM, FDA and ISO standards
• 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 biomedical or mechanical engineering or related field required.
• 3 years of experience in project management required.
• 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.