Senior NPI Engineer

Randstad, as the EMEA Johnson & Johnson talent acquisition partner, is responsible for finding and contracting talent for the contingent roles at Johnson & Johnson. If you are selected for a role you will be engaged or employed by one of the Randstad recruitment companies in EMEA and will not be an employee of Johnson & Johnson. Johnson & Johnson is seeking a Senior NPI Engineer for a role located in Leiden, with a hybrid working model (3 days on-site).

This is a 12-month contract with 40 hours per week. The role involves 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 include: planning, documenting, and executing new process development, designed experiments, validations, qualifications, testing, and design control deliverables; monitoring and supporting new product processes until stabilized; managing and executing projects of moderate to high complexity; providing project management guidance; preparing management reports; developing strategies; setting engineering standards; leading optimization of process output; challenging the status quo; coordinating phases of work; providing technical support; following SOPs and GMPs; revising and maintaining procedures; participating in GMP audits; coordinating communications; participating in projects; writing validation procedures; complying with J&J safety requirements; reviewing and analysing data; demonstrating understanding of GMP fundamentals; communicating business issues; ensuring compliance; and performing other duties as assigned.

To succeed in this role, candidates should have a 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, and a 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 is preferred. Must have fluent and excellent English reading, listening, writing, and speaking.

Experience in collaboration within a team environment across multiple time zones is required. A Credo based working attitude, good leadership and people management, an innovation oriented mind, excellent oral and written communication, advanced computer skills (MS Office, MS Project Management, PowerPoint, Word, Excel, Outlook), experience in a manufacturing environment developing manufacturing standards, proficient project management, experience or knowledge in short and long-term project management, strong organizational and interpersonal skills, ability to prioritize multiple commitments, ability to shift priorities, and ability to periodically interact with associates in a clean room environment are all expected.

Familiarity with Adobe Suite (InDesign or Quark) is a plus but not required. This role offers a very competitive hourly rate and the contract will run for 12 months. Johnson & Johnson is working to create an inclusive environment. The site in Leiden is part of Johnson & Johnson's Mentor division, which sells and produces breast implants for reconstruction and augmentation purposes worldwide. The application process states that the first round of applications will be processed within the next 2 working days, and applications must be submitted directly to the advert (not via email or LinkedIn InMail).