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Consumables Manufacturing Engineer

Ansök    Aug 1    Cepheid AB    Produktionsingenjör, kemi
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas... Visa mer
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible.
Position Summary:
The Consumables Manufacturing Engineer is the primary technical owner for resolving consumable material escalations from production. As the Engineering Subject Matter Expert, the role provides critical support to Manufacturing, Service Technicians, and Production Planning teams, ensuring timely and effective resolution of material-related issues. This includes leading failure investigations and collaborating closely with Supplier Quality & Development, U.S.-based teams, and suppliers.
In addition to escalation management, the engineer supports the qualification of multiple consumable mold tools for assembly lines. These efforts aim to increase material capacity and enhance manufacturing flexibility. Key tasks include designing engineering studies, overseeing the execution of qualification tests, contributing to mold tooling validation, and authoring protocols and reports.
This position is part of the Engineering Department and will be located in Solna, Stockholm, Sweden.
In this role, you will have the opportunity to:
Act as the technical lead for consumable material escalations from production, including root cause investigations, non-conformance (NC) handling, and resolution ownership.
Serve as the Engineering expert for Manufacturing, Service Technicians, Supply Chain, Supplier Quality, collaborating with Solna & US-based teams and suppliers to resolve material issues.
Design engineering testing studies and coordinate lab testing and qualification activities for consumables components.
Provide investigation updates and outcomes to production teams and technicians; actively participate in daily production meetings.
Lead tool validations and support continuous improvement initiatives in the testing lab, including development of new test methods and measurement techniques.
Develop metrology programs on automated Coordinate Measuring Machines (CMM) and wide-area 3D measurement systems; perform Test Method Validation (TMV).
Design custom fixtures and procedures for measurement, testing, inspection, or functional evaluation of consumables parts.
Drive innovation in test methodology and lab practices to enhance detection and resolution of material issues in production.

The essential requirements of the job include:
Education or Experience:
Bachelor’s or Master’s degree in Mechanical Engineering, Production Engineering and Management, Materials Science, Materials Engineering, Plastics Engineering, or a related field with minimum of 2 years of relevant experience in engineering or manufacturing environments.

Knowledge and Skills
Understanding of validation and verification processes for consumables components.
Experience with engineering investigations in high-speed automation environments.
Demonstrated problem-solving skills and ability to lead root cause investigation.
Experience in cross-functional work communication environments, especially across global teams, to ensure alignment and timely resolution of material and production issues.
Ability to develop engineering testing studies, perform test method validations and document procedures with clear work instructions.
Familiarity with quality statistical techniques and metrology tools, including Coordinate Measuring Machines (CMM) and Micro-Vu InSpec (preferred).
Understanding of mechanical assembly, testing, and inspection processes.
Understanding of injection moulding. Familiarity with plastic materials, their behavior in production, and supplier quality collaboration.
Understanding of tool validations, resin changes, and material escalation.

Physical requirements/abilities:
Ability to work in an office, laboratory and production environment

It would be a plus if you also possess previous experience in:
Experience in medical device industry.
Writing and executing validation protocols (IQ, OQ & PQ) and reports.
Experience or coursework in plastics engineering, metrology, quality systems, or statistical process control (SPC).
Oral and written communication skills in Swedish. Visa mindre

Manufacturing Engineer

Ansök    Nov 27    Cepheid AB    Produktionsingenjör, kemi
Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. In our facilities in Solna / Sundbyberg we develop and manufacture diagnostics tests that improve patient outcome all over the world. Were looking to hire a manufacturing engineer to join our team of experts supporting our production lines. In this role, you provide s... Visa mer
Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. In our facilities in Solna / Sundbyberg we develop and manufacture diagnostics tests that improve patient outcome all over the world.
Were looking to hire a manufacturing engineer to join our team of experts supporting our production lines. In this role, you provide support for validation of new equipment and participating in driving continuous improvement activities.


The manufacturing engineer will also be responsible for identifying improvements to existing manufacturing processes on automated assembly lines and actively participate in a hands-on capacity with the modification and upgrading of existing equipment.
Responsibilities include:


Taking ownership of production lines, resolve manufacturability issues, and drive improvements for cost and efficiency.
Supports, maintains, improves modifies and further develops the manufacturing lines as needed for sustaining production.
Leads/participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining work flow.
Support the validation and qualification activities for new equipment and processes.
Design, document, assemble, qualify and introduce production assembly/test/inspection fixtures and equipment
Designs and creates production equipment, fixtures and tests as needed to build the production line either internally or as needed at suppliers.

Knowledge and skills (required):


Bachelor's degree with +3 years’ experience as design or manufacturing engineer.
Demonstrated knowledge of mechanical assembly, testing, and inspection processes and Lean principles.
Medical Device, cGMP and ISO-13485 experience required.
Strong problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments.
Comfortable interacting with technicians, engineers, and management on a regular basis.
Strong technical skills in prototyping, tooling development and troubleshooting.
Excellent oral and written communication skills in Swedish and English.


Preferred qualifications:


Experience in the Medical device field
Experience in writing and execute validation protocols (IQ, OQ & PQ) and reports
Working knowledge of process engineering software packages
Conceptual understanding of automation equipment
3D CAD skills (Solidworks preferred).

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. Visa mindre