Senior R&D Engineer

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 Senior Research and Development Engineer leads research, design, and development of components and complex assemblies for critical bioprocessing applications. This individual will support innovation and product development through all stages, from ideation and concept, to prototyping, and through commercialization. Research and Development will result in deliverables and turnover packages that support swift industrialization.

Essential Functions

• Stay current with emerging technologies, materials, and industry trends to maintain competitive advantage.
• Drive innovation by exploring new technologies, tools, and methodologies.
• Support intellectual property strategies by identifying patentable technologies and working with the legal team.
• Partner with cross-functional teams to ensure successful product development and launch, adhering to established stage-gated process and governance model.
• Effectively project manage timelines, budgets, and resources to deliver high-quality results.
• Oversee the planning, design, development, prototyping, testing, and validation of new products and technologies.
• Conduct risk assessments using FMEA framework and drive risk mitigations as required.
• Lead design and drawing reviews as needed.
• Ensure compliance with applicable regulatory, safety, and quality standards throughout the development process.
• Lead problem-solving, corrective, and preventative actions around product concerns originating both external and internal to the organization.
• Analyze data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Maintain technical records within design history files.
• Drive continuous improvement in product performance, design for manufacturability (DFM), and design for cost-effectiveness (DTC).
• Develop and implement engineering best practices, design standards, and documentation protocols.
• Author SOPs, Work Instructions, and Templates.
• Support Product Delivery Teams (PDT), including creating and/or reviewing quality documents, participating in Corrective and Preventive Action (CAPA) implementation, and generating or supporting ECR (Engineering Change Request) and ECO (Engineering Change Order) activities.
• Perform other duties as assigned.

Education

• Bachelor’s degree in Mechanical, Electrical, Biomedical, or related Engineering field; Master’s degree preferred.

Required Experience & Competencies

• 7+ years of engineering experience within a biotechnology or pharmaceutical manufacturing facility.
• 4+ years of Single-Use Technology (SUT) design experience.
• Preferred experience includes design with tubing, bags, and filling needles.
• Demonstrated expertise in the design of molded plastic parts and assemblies for fluid handling of leak-proof applications.
• Thorough understanding of industry standards and regulatory guidelines.
• Knowledge of ISO 13485, ASME BPE, or related design standards.
• Proven track record in product development, from concept through commercialization.
• Ability to manage multiple projects in a fast-paced, collaborative environment.
• Results-driven mindset with a keen sense of urgency and ability to deliver ahead of deadlines.
• Demonstrated attention to detail with excellent follow-up skills.
• Must be self-motivated, amenable to a variety of work projects, and able to work efficiently independently and as part of a team.
• Strong knowledge of design controls, prototyping technologies such as 3D printing, testing, and validation methodologies.
• Able to read, 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.
• Maintain organized and controlled records of all drawings and BOMs.
• Drive and facilitate assigned portions of product change management and control.
• Solid understanding of mathematical fundamentals of plane and solid geometry, fractions, percentages, ratios, and proportions applied to practical situations.
• Ability to interpret complex data sets, identify patterns, and draw meaningful conclusions.
• Expert knowledge and demonstrated hands-on experience with CAD software, both 3D and 2D.
• Proficient with Microsoft Office Suite or related software.
• Excellent verbal and written communication skills.
• Strong interpersonal skills with the ability to interact with staff at all levels within the organization.
• Proactive approach to identifying opportunities for improvement and driving positive change.
• Develop and maintain positive rapport and working relationships with other personnel across the organization in support of initiatives to execute product improvements and enhancements.
• Experience working in a GMP (Good Manufacturing Practice) or laboratory environment.

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.