Sr. Project Engineer
Mentor Medical Systems BV is recruiting for a Sr. 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 Sr. Project Engineer, you manage and/or execute projects of moderate level to high 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.
Acts as project lead at appropriate stages from User Requirement Specification to final completion.
· Establishes alignment with project sponsor and aligns core and extended team to deliver the final project objectives, including validation and implementation strategy.
· Prepares project charter, including scoping, business case analysis, alternative assessment, presenting the selected option and alternatives for project approval.
· Facilitates the project planning, tracking and reporting against project key deliverables and objectives.
· Oversees project finances: securing accurate budget allocation upon project approval and effectively managing expenses throughout project implementation.
· Responsible for all project engineering activities from early conceptual design to construction, including managing internal project resources and procurement of third-party contractors and suppliers.
· Uses risk management methodologies to identify and manage risks to project objectives.
· Leads project close out activities including operational handover, archiving, financial project closure, collation of benchmarking information and lessons learned to ensure continuous improvement.
· Maintains awareness of external environment, supplying value and insights
- Minimum an Engineering Bachelor degree or equivalent. Master degree is a plus
Experience and Skills:
- Up to 4 to 6 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
- 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