Job Description

Job Description

Job Description

ABOUT SANISURE

SaniSure is a multinational manufacturer of single-use bioprocessing solutions (SUT) used in the production of biological drugs, including monoclonal antibodies, cell therapies, gene therapies, and vaccines. With operations in the U.S. and in Europe, SaniSure operates a leading platform of vertically integrated critical fluid management technologies and integrated solutions. Its single-use products and system solutions are sold to global pharma and biotech companies and are used from R&D through full-scale commercial cGMP manufacturing of among the most innovative large molecule therapeutics and vaccines. This role is expected to be on-site.

We continue to be on a robust growth trajectory, via both organic and inorganic growth, as the company capitalizes on increasing global demand and continues its transition from a component manufacturer to an integrated systems and solutions provider.

Our primary offering includes high-value assembly solutions and a portfolio of market-leading products, including PharmaTainer bottles and carboys and related assemblies, Mixed4Sure mixing solutions, Flex4Sure bags and bag assemblies, Fill4Sure needles and needle assemblies, fittings, clamps and a wide range of silicone, braided and thermoplastic tubing solutions. The company has a growing portfolio of innovative solutions serving fast-growth applications, such as cell and gene therapies.

SaniSure is a high-growth, nimble and innovative company with a strong customer and market focus. Join us and grow your career at SaniSure!

SUMMARY :

A Tool and Mold Designer and Maker is responsible for creating precise designs and plans for tools, molds, and dies used in manufacturing processes. They work closely with engineers, machinists, and production teams to ensure that the tools and molds meet specific requirements, are cost-effective, and facilitate efficient production

ESSENTIAL FUNCTIONS:

• Create detailed 2D and 3D designs for tools, molds, and dies using CAD software.
• Develop innovative designs that meet project specifications, tolerances, and material properties.
• Ensure that designs are optimized for manufacturability, durability, and cost-effectiveness.
• Make the molds
• Work closely with engineers, product designers, and production teams to understand project requirements and constraints.
• Collaborate with machinists and production staff to ensure designs can be accurately and efficiently manufactured.
• Participate in design reviews, provide technical insights, and implement feedback.
• Oversee the prototyping process, ensuring that molds and tools are produced according to design specifications.
• Conduct tests on prototypes to validate the design, ensuring functionality, durability, and performance.
• Analyze test results and make necessary modifications to improve design quality.
• Prepare detailed design documentation, including drawings, material specifications, and assembly instructions.
• Maintain accurate records of design changes, revisions, and approvals.
• Generate bills of materials (BOM) and other required documentation for manufacturing.
• Ensure that all designs adhere to industry standards, safety regulations, and company quality requirements.
• Identify and address potential design flaws or production issues early in the development process.
• Work with the quality assurance team to implement and maintain quality control procedures.
• Stay updated on the latest industry trends, technologies, and materials related to tool and mold design.
• Identify opportunities for process improvement, cost reduction, and efficiency gains.
• Participate in continuous improvement initiatives and training programs.
• Other duties as assigned.

QUALIFICATIONS:

• Bachelor’s degree in Mechanical Engineering, Industrial Design, or a related field.
• Relevant certifications in CAD, CAM, or tool and mold design are a plus.
• Minimum of 3-5 years of experience in tool and mold design or a similar role.
• Experience in the manufacturing industry, with knowledge of production processes and materials.
• Outstanding leadership and motivation skills
• Proficiency in CAD software (e.g., SolidWorks, Mastercam).
• Understanding of manufacturing processes, materials, and tolerances.
• Knowledge of GD&T (Geometric Dimensioning and Tolerancing).
• Experience with simulation software for mold flow analysis is an advantage
• Strong people skills: ability to interact with staff on all levels.
• Strategic mindset
• Exceptional project management skills
• Proven presentation skills and ability to communicate effectively, both verbally and in writing.

PREFERRED QUALIFICAITONS

• Experience working inside the biopharmaceutical industry
• Single Use System design and development experience
• Experience with polymer science, engineering, and manufacturing processes
• Design verification and process verification/validation protocol and report writing
• Execution and documentation of Root Cause Analysis and corresponding Corrective Actions (CAPAs)
• Lean and Six Sigma certification and demonstrated application
• Process characterization experience applying Design of Experiments to optimize manufacturing processes
• Design for Manufacture & Assembly (DFMA) experience reducing cost and quality issues
• Statistical Process Control (SPC) experience

SaniSure is an Equal Employment Opportunity Employer.

SaniSure does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age, military and/or veteran status or any other basis protected by federal or state law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at humanresources@sanisure.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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