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Staff Eng Project Engineering
Description
Job Title: Staff Project Engineer
Location: Mentor Medical, Leiden
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
https://www.jnj.com/.
JOB SUMMARY
Under the direction of the Principal Engineer, the Staff Engineer is a key Engineering position focusing on plant engineering and validation activities at the medical device manufacturing site. The Staff Engineer manages and executes multi-disciplinary cross departmental projects regarding capacity increase, EHS, QA, business continuity and cost improvement. This includes problem identification and definition, root cause analysis, project management, financial analysis, project development, efficiency or productivity improvement, and problem resolution including the required validation activities.
SECTION 2: DUTIES & RESPONSIBILITIES
General Duties:
· Manages and executes projects of high level of complexity ensuring safety, regulatory compliance, company standards, operation requirements and business.
· Development and execution of project specific validation strategies including the development of test protocols and reports ensuring cross functional alignment.
· Ensures effective project planning and structure.
· Supports Operations regarding 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.
· Provides technical support to Operations in evaluating process deficiencies, process changes, modifications and equipment failure.
· Supports manufacturing in the third line troubleshooting of equipment.
· Coordinates communications and interfaces within end users (Mentor) and machine manufacturers or suppliers.
· Comply with all applicable quality management system, environmental, safety and occupational health policies.
Safety and Quality Duties:
· Responsible for communicating business related issues or opportunities to the next management level.
· Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
· For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
· Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
· Performs other duties assigned as needed.
Qualifications
EXPERIENCE AND EDUCATION
· A minimum of a bachelor's degree in engineering or a science discipline is required. A master's degree in engineering is a plus.
Required Experience:
· A total of 5 to 10 years of experience in engineering in a medical device's environment is required.
· Project management skills and training.
· Experience with leading validation activities including protocol and report generation (E.g. FAT, SAT, IQ, OQ, PQ )
· Must have knowledge of the following key regulations and standards: QSR, Medical Device Directory, Canadian Medical Device Regulations, ISO 13485 and 21CFR820.
· Must have knowledge of Project development, stage of project.
· Advanced computer skills and use of software application(s). Strong computer background (MS Office, MS project Management, Power Point, Word, Excel, Outlook, Minitab)
· Experience in a manufacturing environment developing manufacturing standards.
· Experience of 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 ability.
· Ability to shift priorities according to changes in Project need and be open to different ideas/approaches.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
· Knowledge - Has significant knowledge of technical field.
· Leadership - provides significant contributions of project team and lead multi-functional teams addressing big projects. Broadens sphere of influence, including outside contracts.
· Financial management and scheduling - Prepare project estimates for design, equipment installation, labor, materials and other related costs. Prepare project forecast and schedules and track costs.
· Initiative - Works independently and develops own methods, Takes actions in the absence of specific instruction. Develops and presents new or improved methods.
· Contacts - engaged in contact with personnel at all levels within the organization.
· Dutch and/or English
· Ability to read, analyzes, and interprets general business periodicals, technical procedures, or governmental regulations.
· Ability to write protocols and reports, business correspondence, and procedures.
· Ability to effectively present information and respond to questions from groups of managers, customers and other employees of the organization.
We invite you to join our Global Talent Hub, where we keep in touch with people around the world who share our passions for bold innovations and are inspired by our mission of changing the trajectory of human health.
Except as specifically requested by J&J China or legally required, please avoid submitting information in your application which may be deemed as sensitive personal information, which includes biometrics, religious belief, specific identity, medical health, financial accounts, whereabouts, as well as information of minors under the age of fourteen (14), and other information that the breach or illegal use of which may easily lead to the infringement of an individual's personal dignity or harm to personal or property safety.
Processing Method: Conduct talent acquisition management through the unified process and globally connected applications, including storage, use, handling, transmission, and deletion of provided personal information. Overseas recipients will apply appropriate managerial and technical measures to ensure the confidentiality, integrity, and availability of the provided personal information and shall store such personal information to the minimum extent necessary to complete the above purposes.
,、、。
You may contact the Personal Information Protection Officer of the J&J China at to exercise your relevant rights to the overseas recipient, including access, correct, copy, or delete your personal information.
Functie: | staff project engineer |
Startdatum: | 30-05-2024 |
Ervaring: | Ervaren |
Educatielevel: | HBO |
Contracttype: | Vast |
Salaris: | onbekend – onbekend |
Uren per week: | 1 – 40 |
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