Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

LCE Specialist, Medical Device Lifecycle Engineering (m/f/d)

Your tasks and responsibilities

  • Lead lifecycle-engineering projects and activities in cross-functional teams including manufacturing, procurement, development, quality, supply chain and other key stakeholders
  • Perform medical device changes, enhancements and corrections founded in structured root cause analyses, risk analyses and customer feedback
  • Ensure product availability by proactively monitoring material or component obsolescence notifications and re-designing as needed to maintain product supply continuity
  • Lead assigned corrective and preventive actions as part of ongoing continuous improvement objectives
  • Identify value engineering opportunities and implement design changes aimed at reducing cost of goods
  • Proactively lead design changes to maintain global compliance to applicable industry and regulatory standards
  • Support Design Control documentation (write and/or review)
  • Securing product quality, safety and compliance with regulatory requirements for medical devices, often in combination with drug products.
  • Secure a continuous improvement mindset in the team applied to engineering and documentation processes
  • Work closely with counterparts in Product Supply, R&D, RA and QA globally as well as with external partners and suppliers
  • Your team is part of the Medical Device Manufacturing Science & Technology function. You report directly to Head of Medical Device LCE Director

 

Who you are

  • Advanced degree in Engineering (Mechanical, Electrical, Instrumentation), Polymer Chemistry, Life Science or related 
  • Minimum of severals years working with life cycle engineering/product sustaining, manufacturing and/or development of medical devices in medical device or pharmaceutical industry (solid experience with drug-device combination products)
  • Project management skills with the ability to motivate and manage a team within a matrix organization
  • Expertise in medical device manufacturing technologies, such as sterilization, assembly, injection molding/ extrusion, packaging a.o.
  • Demonstrated ability to drive for results as well as to simplify and improve business processes
  • Lean, Six Sigma training and certification preferred
  • Strong knowledge of quality systems, including requirements described by ISO13485, ISO 14971, FDA CFR Part 820 and GxP
  • Willingness to travel globally 
  • Fluent English, both written and verbal; German desired but not mandatory

 

 

 

Your application

Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.

 

 

 

Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. 

Country: Germany
Location: Berlin
Reference Code: 34844
Functional Area:
Entry Level: