About SaniSure
SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today's most innovative and life-changing medicines.
As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.
Job Summary
The Engineering Documentation Specialist is responsible for developing and maintaining accurate engineering drawings, bills of materials (BoMs), and product documentation that support customer-specific product development. This role partners closely with Sales, Engineering, Product Management, Operations, Supply Chain, Manufacturing, and Quality to ensure product documentation is complete, accurate, and properly controlled throughout the product lifecycle. It applies strong CAD drafting expertise, ERP/BoM management experience, and an understanding of manufacturing processes within a regulated environment, operating with a high degree of independence while ensuring engineering documentation supports efficient production and continuous improvement.
Essential Functions
- Create and maintain detailed 2D and 3D engineering drawings using CAD software in accordance with company and industry standards.
- Translate engineering concepts, design requirements, and technical specifications into accurate manufacturing documentation.
- Review drawings for completeness, manufacturability, and compliance with engineering standards.
- Create, maintain, and revise multi-level BoMs within the ERP/MRP system, ensuring they accurately reflect engineering designs, approved materials, purchased components, and manufacturing requirements.
- Coordinate BoM updates resulting from engineering changes, supplier modifications, cost reductions, and product improvements.
- Administer engineering documentation through established document control and Engineering Change Order (ECO) processes; maintain revision history and ensure records remain accurate, traceable, and audit ready.
- Prepare and author engineering documentation, including Root Cause Corrective Action (RCCA) reports, engineering reports, and technical memoranda.
- Communicate approved engineering changes to Manufacturing, Supply Chain, Quality, and other affected departments.
- Collaborate with Design Engineering, R&D, Product Management, Manufacturing, Procurement, and Quality to support new product introductions and ongoing product improvements.
- Assist with component selection, material sourcing, and documentation required for new product development.
- Support manufacturing by resolving drawing discrepancies and documentation issues.
- Perform quality reviews of engineering drawings, BoMs, and related documentation to ensure accuracy and consistency.
- Recommend improvements to drafting standards, document control practices, and BoM management processes.
- Mentor less experienced drafting personnel as needed.
- Perform other duties as assigned.
Education
- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Engineering Technology, or a related discipline.
Required Experience & Competencies
- Experience supporting manufacturing or product development environments.
- Proficiency with SolidWorks, AutoCAD, or similar CAD platforms.
- Experience maintaining engineering documentation within ERP/MRP systems.
- Experience using Engineering Change Orders (ECOs) or Product Lifecycle Management (PLM) systems.
- Experience in medical device, biopharmaceutical, life sciences, or other FDA/ISO-regulated manufacturing environments preferred.
- Strong mechanical aptitude and understanding of manufacturing processes.
- Excellent attention to detail with exceptional documentation accuracy.
- Working knowledge of document control principles and engineering change management.
- Ability to interpret engineering specifications and technical drawings.
- Strong organizational and project management skills, with the ability to manage multiple priorities and meet deadlines.
- Effective verbal and written communication skills; a collaborative team member who builds effective working relationships across departments.
- Self-directed with strong ownership and accountability; demonstrates composure and sound judgment under pressure.
- Proficiency with Microsoft Office and ERP/MRP systems; experience with Visio is a plus.
Equal Employment Opportunity Policy
We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion (including religious dress and grooming practices), color, sex (including childbirth, breast feeding, and related medical conditions), gender identity or expression, sexual orientation, national origin, citizenship status, uniform service member status, pregnancy, age (40 and over), genetic information, disability (mental and physical), or any other protected status in accordance with all applicable federal, state, and local laws.
Skills Required
- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Engineering Technology, or a related discipline
- Experience supporting manufacturing or product development environments
- Proficiency with SolidWorks, AutoCAD, or similar CAD platforms
- Experience maintaining engineering documentation within ERP/MRP systems
- Experience using Engineering Change Orders or Product Lifecycle Management systems
- Experience in medical device, biopharmaceutical, life sciences, or other FDA/ISO-regulated manufacturing environments
- Strong mechanical aptitude and understanding of manufacturing processes
- Exceptional documentation accuracy and attention to detail
- Working knowledge of document control principles and engineering change management
- Ability to interpret engineering specifications and technical drawings
- Strong organizational and project management skills, including managing multiple priorities and meeting deadlines
- Effective verbal and written communication skills and ability to collaborate across departments
- Self-directed with strong ownership, accountability, composure, and sound judgment
- Proficiency with Microsoft Office and ERP/MRP systems
- Experience with Visio
What We Do
As your trusted Single-Use Technologies (SUT) expert, SaniSure® designs and manufactures components, fluid management systems, and custom assemblies for complex fluid paths and closed-system applications across bioprocessing and advanced therapies—from upstream processing through final fill. With expertise in single-use system design, materials, and manufacturing, SaniSure works directly with customers to develop solutions tailored to their specific process requirements. Its open-architecture approach provides the flexibility to integrate components and technologies based on application needs rather than being limited to proprietary configurations. SaniSure combines in-house engineering, prototyping, component manufacturing, and assembly capabilities with a global manufacturing footprint. This vertical integration provides greater control over component sourcing, design, manufacturing, and quality. Through its broad component portfolio, custom engineering capabilities, and integrated manufacturing operations, SaniSure helps biomanufacturers address complex fluid management requirements, reduce supplier complexity, and support reliable manufacturing operations.
