Description

Mentor Medical Systems BV is recruiting for a Project Engineer, located in Leiden, The Netherlands.

Mentor Medical Systems BV is known worldwide as a world-class manufacturer and supplier of medical products. We offer a position in a fast growing, diverse and international organization as we are part of the big American pharmacist Johnson & Johnson since 2009. The company's headquarters are located in Santa Barbara, California (USA). We, as Mentor Leiden, develop and produce high-quality breast implants that are used in plastic surgery.

As a Project Engineer, you manage and/or execute projects of low to moderate level complexity ensuring safety, regulatory compliance, company standards, operation requirements and business needs are met.

You will be part of a project team or lead a project team according to the desired working method, J&J Credo, Safety requirements, GMP regulations and ISO and quality standards.

Besides that, you also ensure that the (project) team functions in a motivating and pleasant manner according to our cultural values.

Key Responsibilities:

Engineering activities

o   Provides technical support for development or modification of process equipment

Validation of equipment activities

o   Write and execute validation protocols and test plans that outline the validation approach, testing procedures, acceptance criteria, and relevant documentation as part of the assigned projects

• Execute validation tests on equipment, which may include performance, functionality, and operational tests.

Data Collection and Analysis:

o   Collect and record validation data meticulously during testing procedures.

o   Analyze collected data to determine if equipment performance meets predetermined acceptance criteria.

o   Identify and document any deviations from expected results and collaborate with relevant teams to address them.

Report Writing:

• Compile validation test results, observations, and conclusions into clear and concise validation reports.
• Ensure that validation reports are accurate, detailed, and compliant with regulatory requirements.
• Clearly communicate the results, deviations, and any corrective actions taken.

Documentation and Record Keeping:

• Maintain a well-organized and up-to-date record of validation documentation and reports.
• Manage electronic systems and databases for tracking validation activities and outcomes.
• Ensure that all documentation is easily accessible and retrievable for audits and reference.

Process Improvement:

• Contribute ideas for enhancing the current processes, streamlining procedures, and improving efficiency.

Qualifications

Education:

• Minimum an Engineering Bachelor degree or equivalent. Master degree is a plus

Experience and Skills:

Required:

• Up to 2 to 4 years experience in Medical Device industry (Engineering) and capable to structure and manage a team
• Strong organizational, interpersonal, oral and written communication skills to ensure good communication to the team, to the internal customer and other stakeholders. English is required, Dutch is appreciated
• Proven Technical expertise
• Strong Project Management skills
• Knowledge in validation of complex equipment according ISO 13485 / ISO 9001 / 21 CFR 820 FDA regulation – medical device regulations
• Ability to prioritize multiple commitments

Preferred:

• Knowledge of Process Excellence tools like Six sigma, Lean, DMAIC, etc.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com