Job Description

Be part of something altogether life-changing

Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity so you can grow your career and expand your skills in the long term.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, were pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

What youll do

* Interface directly with customers, suppliers, and internal teams to resolve customer complaint investigations, drive root cause analysis to implement design, process, and supplier quality related solutions.
* Support the design, testing and release single-use consumable products, components, assemblies, packaging, tooling, and fixtures. Analyse and validate custom designs per user requirements to meet performance, cost, compliance, and manufacturability targets.
* Support product design to meet their intended use. Ensure performance of engineering analyses (support and review FEA, CFD analyses) to lead design decisions.
* Create and maintain DHF; detail drawings, specifications, assembly drawings and associated Bill-of-Materials, manufacturing documents, including initial assembly instructions, inspection criteria and packaging instructions.
* Verify product performance against design inputs. Write verification protocols, perform testing, analyze, and interpret test data, write and present verification reports.
* Create manufacturing documents, including initial assembly instructions, inspection specifications, component specifications, and packaging instructions.
* Release products through the ECR/ECO process.
* Lead CAPA activities and complete Customer Complaint records in the Veeva system.
* Coordinate project priorities with team and Product Managers.
* Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.
* Maintain a safe work area.

Who you are

* Bachelor's degree in either; BioEngineering, Biomedical Engineering, Mechanical Engineering, Chemical Engineering or Plastics Engineering.
* Minimum of 1 year relevant experience in either; Bioprocessing, Pharma, or related Biotechnology field of work such as medical devices.
* Experience in CAD systems; SolidWorks, Pro/ENGINEER and/or CREO using PDM/PLM systems.
* Experience in plastic part design and GD&T per ASME Y14.5 standards.
* Working knowledge of plastic material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
* Knowledge of biocompatible material selection for sterile single-use applications in bioprocessing and/or medical device applications.
* Awareness of GMP and governmental regulations related to drug manufacturing sufficient to appreciate the need for documentation accuracy.
* Ability to read and interpret professional journals and technical procedures, write test protocols and reports; communicate test analysis and results.
* Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.
* Hands-on experience designing, prototyping and testing of components and assemblies.
* Excellent communication and influencing skills and ability to gain buy-in for initiatives.

Desired

* Masters degree in Engineering
* Proficient with MS Project to create Project Plans, Work Breakdown Structures (WBS) and Gantt chart schedules.
* Experience in CAE analysis tools; FEA, CFD and MoldFlow.
* Outstanding communication and writing skills for working with global manufacturing, marketing, and development teams.
* Experience in leading projects/activities to meet customer requirements.
* Familiarity with relevant regulatory and Q/A guidelines governing single-use plastic components such as Biocompatibility requirements per USP Class VI and ISO-10993.
* Six Sigma Certification (Green Belt, Black Belt) or knowledge of DFSS.
* Experience working in an Agile work environment with Scrum teams.
* Application of Risk Management methodologies to aid in meeting commitments

When you join us, youll also be joining Danahers global organization, where 68,000 people wake up every day determined to help our customers win. As an associate, youll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why well empower you to push the boundaries of whats possible.

If youve ever wondered whats within you, theres no better time to find out.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The EEO is the Law poster is available here.