Senior Engineer

Senior Engineer - LCM

Location: Leiden, Netherlands 

Duration: 12 months 

Hours: 40 

This position does not accept freelancers 

Imagine your next project leading critical design changes and product lifecycle management for a global leader in medical technology, ensuring life-saving products reach patients safely and efficiently.

The Senior LCM Engineer manages most aspects of multiple projects or initiatives. Role interfaces directly with other facility and corporate functional groups to ensure that goals and objectives are met within GMP/ISO compliance and product design changes are addressed appropriately. Lead multifunctional, cross departmental projects and initiatives geared towards achieving process improvements, cost reductions, new process/product introductions and quality improvement. 

• Senior Engineer LCM is a critical position to be responsible for site products and components life cycle management. 

• Senior Engineer LCM leads low to high- level site products design change, identifies, and follows appropriate quality processes and procedures. 

• Senior Engineer LCM supports new product registration and commercial launch, identifies key steps and leverages global resources. 

• Senior Engineer LCM provides the required documentation and labeling change deliverables to lifecycle design control teams. 

• Senior Engineer LCM is responsible for product master date maintenance and change. Senior Engineer LCM reacts to the product issues in the market, and coordinates between the Research & Development team, Marketing team and Regulatory Affairs to lead relevant projects. 

• Success depends on the depth of knowledge in the design change process and the coordination with the design team, New Product Introduction / Life Cycle Management team, Research & Development team, and other J&J manufacturing teams.

roles and responsibilities. 

The Senior LCM Engineer acts as a critical technical coordinator between design teams and manufacturing, overseeing the entire product life cycle and commercial launch registration.

This will involve:

• Manages and executes projects and/or programs of low to moderate level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met.

• Responsible for providing technical support and be coordinator between component sourcing and suppliers for activities of new material cut in and old material phase out.

• Lead labeling design projects, work closely with global and local teams to make sure the labels meet regulatory and marketing requirements.

• Work with the design team to confirm the manufacturing bill of material, coordinate BOM Drawing, and cooperate with the local engineering team on BOM change and management.

• Leading collaborative team meetings with cross-functional subject matter experts (SME) to arrive at consensus for labeling content changes. Under very limited to no supervision and at times independently coordinates lifecycle product labeling content input collection.

• Represent the Labeling COE to customer groups, and functional business partners, while responding to and/or escalating as appropriate within the labeling COE to meet the needs and respond to requests, escalations and inquiries from the business, as needed.

• Responsible for Unique Device Identification (UDI) application and management, make sure all product UDI complies with local regulatory requirements.

• Overall management of design change projects. Work closely with local and global teams to track projects progress.

• Organize review meetings to identify the process and risks. including risk mitigation.

• Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations.

• Writes, develops and implements validation procedures.

• Comply with J&J Safety Requirements and ensure safe working conditions and practices in the department.

• Reviews and analyses data, understanding of statistics and the application of statistical data, able to determine normal and non-normal data along with probable causes of non-normal results.

• Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Performs other duties assigned as needed

how to succeed. 

To be successful, you will leverage your depth of knowledge in design change processes and your ability to coordinate effectively with global research and development teams.

You will also bring:

• Bachelor’s or master’s degree in an engineering discipline.

• The ideal candidate will possess experience in product design, process design, or a combination of both. While a background in the medical device industry is highly preferred, experience within other highly regulated sectors (e.g., aerospace, automotive, or pharmaceuticals) is also strongly valued

• Must have fluent and excellent English reading, listening, writing, and speaking.

• Experience in collaboration within a team environment across multiple time zones.

• Credo based working attitude, inspire trust and engagement through organization.

• Good leadership and people management.

• Have an innovation orientated mind to drive world-class business results.

• Excellent oral and written communication, good at coordinating different functions and leading a team to complete business goals.

• Advanced computer skills and use of software applications. Strong computer background (MS Office, MS Project Management, PowerPoint, Word, Excel, Outlook etc.).

• Familiar with Adobe Suite such as: InDesign or Quark is a plus but not required.

• Experience in a manufacturing environment developing manufacturing standards

• Proficient in project management, creating credibility within team members and expanding capabilities of the group.

• Experience or knowledge in short and long-term project management.

• Strong Organizational, interpersonal, oral and written communication skills.

• Ability to prioritize multiple commitments and technical problem-solving duties.

• Ability to shift priorities according to changes in department/facility needs and open to different ideas/approaches.

benefits.

This role offers a very competitive hourly rate. This contract will run for 12 months

You are welcome here. 

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

application process. 

We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email.

Diversity, Equity & Inclusion. 

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”