Director of Engineering - Design

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 Director of Engineering – Design is responsible for global product design at SaniSure. Scope includes assuring velocity and efficiency of drawing and Bill of Material throughput while maintaining accuracy and quality, tracking and managing associated key performance indicators (KPIs), selecting and deploying software, training, design tools, and design libraries, authoring and updating design SOPs and Work Instructions, engineering data integrity and data services, and the Engineering portions of product change control and change management, and urgently resolving design-related issues that impact production and end-customers.

Essential Functions

• Manage the global team responsible for computer-aided design (CAD) at SaniSure. Set and continuously improve global CAD standards, templates, design libraries, and assure deployment and training.
• Provide global leadership for deployment of 3D CAD and PDM. Work cross-functionally to build out the global data systems framework.
• Develop deep product knowledge to provide technical design expertise to Sales, Customers, and other functional areas. Consult with other subject matter experts as required.
• Review design requirements inputs from Customers, Sales, and Product Line Managers. Assure requirements are clearly translated into design features. Push for clarity and for closure of gaps in information.
• Serve as the main point of Design contact for major customer Requests for Proposals (RFPs).
• Analyze mechanical designs, including sketches, technical drawings, schematics, specifications and associated product measurements. Conduct risk assessments using FMEA framework, and drive risk mitigations as required. Lead design and drawing reviews as needed.
• Promote the options for presenting alternative designs to customers, especially when it comes to products manufactured by SaniSure.
• Assist engineering personnel with material sourcing for new parts in support of their designs.
• Obtain and assemble data, including product data sheets and material quotes, to complete drawings and bills of materials (BOMs).
• Ensure full technical documentation of designs including BOMs, drawings, schematics, engineering change control, and procedures adhere to customer requirements, industry regulations, and quality standards.
• Assure efficient prioritization and task management. Directly engage in ongoing oversight of turn-around-times for drawings and BOMs. Drive the global team to meet or exceed their objectives for established metrics and Targets To Improve (TTIs), especially time commitments, while maintaining accuracy.
• Work with R&D, New Product Introduction, and with Manufacturing to integrate a Design for Manufacture & Assembly (DFMA) and Design to Cost (DTC) perspective.
• Maintain organized and controlled records of all drawings and BOMs. Drive and facilitate assigned portions of product change management and control.
• Own data integrity and data services when it comes to item master creation and curating assigned product data within SaniSure databases. This includes Product Data Management (PDM) and ERP.
• Support product configuration management.
• Develop and maintain positive rapport and working relationships with other personnel across the organization in support of initiatives to execute product improvements and enhancements.
• Provide technical direction and guidance to less experienced Engineers and Drafters.
• Provide inputs for departmental budgeting, and track and manage to assure spending stays within set parameters.
• Perform other duties as assigned.

Education

• Bachelor's degree in Engineering; Master's preferred.

Required Experience & Competencies

• Single Use Consumable design and development experience, experience working with multiple bioprocessing equipment suppliers.
  
• Minimum 10 years of overall Engineering experience.
• Minimum 5 years in a former role managing a team of Engineers.
• Experience with staffing, and with growing and developing strong teams. This includes active performance management.
• Experience setting top-down department goals and objectives tied to business metrics and driving team performance in the context of business results.
• Expert knowledge and demonstrated hands-on experience with Solidworks CAD software, both 3D and 2D.
• Knowledge of plastic component and tool design, especially injection molding, and some blow molding.
• Able to read and comprehend and interpret documents such as drawings, BOMs, blueprints, and operating procedures. Able to train and guide less experienced personnel on proper interpretation and best practices.
• Advanced understanding of mathematical fundamentals of plane and solid geometry, fractions, percentages, ratios, and proportions to practical situations.
• Design control, change control, risk management experience (FMEA).
• In depth knowledge of creation of 2D and 3D drawings and related Bill of Materials (BoMs).
• Able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Strong MS Office skills, including Excel.
• Strong ERP knowledge, SyteLine preferred.
• Excellent oral and written communication skills.
• Patient, tactful, diplomatic, and approachable.
• Able to represent SaniSure from a position of design expertise when customer-facing.
• Able to stay calm in challenging situations.
• Keen sense of urgency and ability to deliver ahead of deadlines.
• Strong organizational skills and attention to detail.
• Able to establish and maintain effective working relationships.
• Able to effectively work in a fast-paced environment and frequently manage multiple priorities.
• Must be self-motivated, amendable to a variety of work projects and work efficiently independently and as part of a team.
• Excellent follow-up skills.

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.