Senior NPI Engineer

Johnson & Johnson; Leiden; Hybrid; EUR 69,000 - 103,000; Full time

Job summary

Johnson & Johnson Mentor Leiden seeks an experienced project leader to drive NPI programs for class III medical implants. You will manage multi‑disciplinary teams, set timelines, write protocols, and ensure GMP/ISO compliance throughout design changes and packaging labeling activities.

The role emphasizes cross‑functional collaboration with R&D, regulatory, and finance, under ISO 13485, EU MDR, and GMP guidelines.

Qualifications

• Bachelor’s or Master’s degree in engineering with 3–5 years in a GMP/regulatory setting.
• Fluent English reading, listening, writing and speaking.
• Strong project management and communication abilities in a regulated environment.
• Experience collaborating across R&D, regulatory and finance teams.

Responsibilities

• Plan, document, and execute new process development and validation work for high‑quality new products.
• Lead cross‑functional projects to meet time, cost, and margin targets.
• Transfer processes to production and monitor stabilization and scale‑up.
• Provide project management guidance and prepare management reports.

Skills

Project management

Cross-functional collaboration

English fluency

Regulatory compliance

Communication skills

MS Office / Productivity tools

Technical writing

Education

Bachelor’s or Master’s degree in engineering

Tools

MS Project

PowerPoint

Excel

Adobe Suite (InDesign)

Job description

Location: Leiden (Hybrid - 3 days on-site)

Duration: 12 months

Hours: 40 hours per week

Imagine your next project leading impactful new product introductions and manufacturing processes for class III medical implants at a world-class MedTech site.

Under the direction of the applicable Senior NPI Supervisor, this role manages most aspects of multiple projects or initiatives within a combined Lifecycle Management (LCM) and NPI department split into specialized sub-teams. The position 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.

You will lead multifunctional, cross departmental projects and initiatives geared towards achieving process improvements, cost reductions, new process/product introductions, and quality improvement, focusing on new product introductions (NPI) and manufacturing processes for class III medical implants (silicone breast implants and tissue expanders) at a Johnson & Johnson MedTech (Ethicon/breast aesthetics) site. Core duties include setting timelines, writing protocols and reports, cross-functional stakeholder collaboration (R&D, regulatory, finance), and supporting packaging and labelling processes under strict ISO 13485, EU MDR, and GMP compliance.

roles and responsibilities

• Plans, documents, and executes new process development, designed experiments, validations, qualifications, testing, and design control deliverables in order to launch high-quality, compliant new products into manufacturing while meeting time, cost and margin targets.
• Monitors and supports new product processes until stabilized, and fully transferred into production.
• Manages and executes projects and/or programs of moderate to high level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met.
• Provides project management guidance and business tools, utilizing a systematic approach to project execution.
• Prepares management reports and presentations.
• Effective project planning and structure.
• Develops imaginative strategies for the efficient completion of projects.
• Sets the engineering standard and direction for the group and is recognized as the source for guidance in a field.
• Leads the optimization of process output and throughput, equipment utilization, equipment downtime, waste reduction/yield improvements, budget management, standard cost and capital investment management in an innovative manner.
• Challenges the “status quo” on a routine basis and develops new ideas within incoming processes.
• Coordinates phases of work with other departments within the company and with other Ethicon divisions.
• Technical support to Manufacturing Business Units for complex process issues, where higher level of technical expertise in a given field of knowledge is required.
• Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations.
• Revise and maintain engineering, equipment and process procedures.
• Participates in GMP audits regarding equipment recording and machine performance.
• Coordinates communications and interfaces with end users, machine manufacturers and/or suppliers.
• Participates in projects involving other departments and activities (CIM, QIP, CFM, etc.).
• 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

• Bachelor’s or Master’s degree with 3–5 years of experience in a highly regulated or GMP environment, complemented by strong project management and communication skills.
• Bachelor’s or master’s degree in an engineering discipline.
• A minimum of 3-5 years’ work experience in engineering and/or package labelling in a medical device environment preferred.
• 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 innovation orientated mind to drive world-class business result.
• Excellent oral and written communication, good at coordinating different functions and leading 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.
• Ability to periodically interact with associates and processes in a special environment such as a clean room.

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 Mentor, Leiden

Part of Johnson & Johnson, Mentor sells and produces breast implants for reconstruction and augmentation purposes worldwide from their state of the art site in Leiden. With a proud history as a global leader in breast aesthetics, we believe that innovation should be driven by what patients need and should be backed by solid research, high design and thorough testing. Contribute to the next healthcare breakthrough with your next project at Mentor.

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 or LinkedIn InMail - you must apply direct to this advert.

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 belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.