Manager Engineering

Cepheid AB / Kemiingenjörsjobb / Solna
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At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.

We are looking for a Manager for our new VFAL/PAL/ BEAD / PACK Engineering group.

The manufacturing engineering department is responsible for improvement and supporting of VFAL, PAL and BEAD production. The production consists of filling & packaging, preparation of product reagents and freeze drying. The responsibility includes, but is not limited to, availability, performance, and quality in the mechanical, control and process areas. Support is also given to maintenance technicians in form of troubleshooting expertise and trainings in production processes and /or equipment. The department is also responsible for label and packaging evaluation, validation, and maintenance. This includes support of package design, development and testing for diagnostic kits, and all labelling development and implementation.

The Engineering group works close together with other departments i.e., Manufacturing, R&D, Marketing, Failure investigations, Product Transfer, Quality Systems, Service Engineers, Facility, IT.

Job Description
The Engineering manager is responsible for assuring that the manufacturing engineering team works with transfer of new technology, trouble shooting and continuous improvements to assure operations is efficient and delivered with high quality according to set build plans and company & compliance expectations. The responsibilities include:

Lead the development and optimization of new and existing manufacturing processes to ensure launch of new products and to meet future production demands.
Run work with installation and qualification of new manufacturing equipment: process development/optimization, technology transfer, process qualification, process validation.
Manage support to production activities, including trouble shooting, writing of user requirement specifications, writing of production documents such as user manuals.
Assign, develop, and evaluate team members to ensure efficient installation & validation of new equipment & processes and troubleshooting & resolving manufacturing issues
Maintain strict compliance with applicable Quality Management System standards
Reviews change orders and validation workflows in Agile as a representative of Manufacturing Engineering
Provides input for budget/forecast for the department

Knowledge and skills (general and technical):
Required knowledge, skills and abilities (minimal competencies):
Excellent leadership skills and strong ability to engage, empower and develop colleagues
Excellent communication skills both in Swedish & English (oral and written)
Excellent organizational skills
Excellent knowledge of installation & validation of new equipment and processes in a regulated industry
Ability to work independently
Ability to successfully interact with cross-functional teams in a global environment


Minimum qualifications:
MSc in Chemical or Mechanical Engineering or Bachelor's degree with proven experience
Preferred qualifications:
Experience from medical device regulations in US and CE markets
Experience from working in a global environment
Experience from working with automation equipment
Experience from working with freeze-drying and filling processes
Basic experience/ understanding of injection molded parts and relationship of how they interact dimensionally within processing equipment

Physical demands:
Ability to work in an office and production environment

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll 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.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you've ever wondered what's within you, there's no better time to find out.

Publiceringsdatum
2022-03-17

Så ansöker du
Sista dag att ansöka är 2022-04-16
Klicka på denna länk för att göra din ansökan

Adress
Cepheid AB
Röntgenvägen 2
17127 Solna

Omfattning
Detta är ett heltidsjobb.

Arbetsgivare
Cepheid AB (org.nr 556595-6181)
Röntgenvägen 2 (visa karta)
171 27  SOLNA

Jobbnummer
6448539

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