Senior Project Engineer - Birth Tissue

Purpose

The Senior Project Engineer will be responsible for supporting existing products and the development of new products. This will include leading project management, product development, and verification & validation activities.

Responsibilities

• Lead critical or complex product development projects from concept to market launch
• Define project scope and deliverables required for new product development (NPD) and sustaining projects in alignment with cross-functional stakeholders
• Lead project management activities including schedules, budgets, work products, and deliverables with project goals
• Drive achievement of project timelines in support of business objectives
• Define the engineering project approach and own technical project decisions within approved guardrails and alignment with business objectives, escalating items that exceed authority
• Implementation of design control practices for NPD projects and completion of all phase gate deliverables
• This includes collecting market feedback to identify critical product characteristics
• Develop and execute validation protocols in accordance with regulatory requirements
• Review results and author validation reports
• Serve as engineering representative in cross-functional leadership discussions and strategic decision-making
• Lead multi-disciplinary teams, driving accountability and timely delivery across functions
• Mentor and provide technical guidance to Project Engineers and Associate Project Engineers on product design, manufacturing process, troubleshooting, engineering drawings, and design controls
• Develop and review risk management documents such as failure modes and effects analysis (FMEA)
• Proactively identify operational or engineering process gaps and lead cross-functional efforts to address them
• Collaborate with the QA/RA departments on the development of supplier agreements, labeling, product claims, regulatory submissions, regulatory strategies, and sales & marketing materials
• Lead cross functional and executive updates to provide project status, risks, mitigations, impacts, and achieve cross-functional alignment
• Develop scalable manufacturing processes for new products in collaboration with the Research, Quality Assurance (QA), and Operations departments
• Draft, revise and maintain standard operating procedures (SOPs) in accordance with FDA, AATB, and other regulations, standards
• Review, analyze, and characterize critical financial characteristics of products including BOMs and COGS
• Lead the design transfer of new products to the Operations department
• This includes conducting group training for new products, processes, and associated equipment
• Oversee and manage processing of human tissue as part of the development of new processes
• Design and execute study experiments for product development projects
• Complete data collection, data analysis, and reports
• Execute and plan new company initiatives including product development, continuous improvement, cost reductions, and others
• Design and develop proprietary manufacturing fixtures and equipment. Order and evaluate commercial equipment to support new or existing manufacturing processes
• Assist with investigation of product quality events such as CAPAs and Non-conformances
• Implement and identify ASTM, AAMI, ISO, or other relevant testing standards 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
• 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
• Report to work in-person and start job on time for established shift
• Perform other duties as assigned

Skills

• Excellent technical writing skills
• Capable of working independently and in a team environment
• Experience working in a cleanroom manufacturing environment
• Experience with validation procedures
• Strong analytical and creative thinking skills
• Experience working with vendors and suppliers
• Excellent attention to detail and organization
• Excellent written and verbal communication
• Ability to multi-task and work in a fast-paced environment
• Effective project management experience
• Proficiency in Microsoft Office

Qualifications/Requirements

• Bachelor’s degree in biomedical engineering, tissue engineering, mechanical engineering, or related field required
• Master’s degree in biomedical engineering, tissue engineering, mechanical engineering, or related field preferred
• 5 years of product development experience required
• 4 years of project management experience required
• Strong mechanical design and 3D modeling experience required
• Manufacturing process design experience required
• Tissue handling experience preferred
• Working knowledge of design control processes required
• Experience with HCT/Ps and/or medical devices required
• Clearance of favorable background investigation required