Senior Project Engineer

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