Senior development engineering

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.

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.

Stay current with emerging technologies, materials, and industry trends to maintain competitive advantage.

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.

Analyze data from validation tests to determine whether systems and processes meet required criteria and specifications.

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. 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.

Bachelor’s degree in Mechanical, Electrical, Biomedical, or related Engineering field; 7+ years of engineering experience within a biotechnology or pharmaceutical manufacturing facility.

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. Proven track record in product development, from concept through commercialization.

Ability to manage multiple projects in a fast-paced, collaborative environment. 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.

Ability to read, comprehend, and interpret documents such as drawings, BOMs, blueprints, and operating procedures. Ability to interpret complex data sets, identify patterns, and draw meaningful conclusions. Author scientific reports with conclusions and recommendations. Use data to drive decisions tied to the business context.

Expert knowledge and demonstrated hands‑on experience with CAD software, both 3D and 2D.

Proficient with Microsoft Office Suite or related software.

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.

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