PM Engineer Process Engineering
Johnson and Johnson is recruiting for a PM Engineer Process Engineering.Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science – bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.Having made significant contributions to healthcare for more than a century, the Johnson & Johnson MedTech Companies are in the business of reaching more patients and restoring more lives. The group represents the most comprehensive surgical technology and specialty solutions business in the world, offering an unparalleled breadth of products, services, programs and research and development capabilities directed at advancing patient care while delivering clinical and economic value to health care systems worldwide.Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.JOB SUMMARYResponsible for providing advanced engineering, design, and construction of manufacturing facilities, systems, and equipment; and providing engineering and technical support for complex production and processing equipment.Provides process engineering and controls support Plans and conducts activities related to the development or new processes including researching current and emerging technologies, evaluating process cost, quality, and capability alternatives, and performing process characterization and optimization using design of experiments, problem solving and decision-making tools. Provides technical expertise in troubleshooting, design, and construction of manufacturing processes, systems and equipment. Plans, coordinates, documents, and implements all qualification and validation activities of new or improved manufacturing processes equipment and processes. Ensures fulfillment of all regulatory, safety, industrial hygiene and environmental requirements for implementation of new products, processes, and equipment.DUTIES & RESPONSIBILITIESUnder limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Ensure equipment uptime through the expedient, effective resolutions of production equipment problems to meet customer service objectives for line fill rates.
Troubleshoot issues related to part quality, as well as lead implementation of changes to correct.
Preparation of strategies, products, data collection, data analysis and presentation completion reports and document change package preparation.
Independently perform process and project activities and general instruction.
Manage line priorities to assure that all activity is directed in alignment with Business Unit objectives.
Serve as the process technical expert for one area within the plant.
Provide an ongoing analysis of current process capability to assure existing manufacturing systems are sufficient to achieve company objectives.
Recommend and coordinate process improvement activities with the Line Support and Operations groups.
Manages contract validation resources or other resources as required to achieve project objectives.
Manage medium to large scale capital projects.
Supervises engineers and associates, if necessary.
Prepares, discusses, documents, sets goals and measures above activities.
Interfaces with other plant locations such as Corporate and external vendors to ensure that the facility’s goals, objectives and requirements are met: included are project schedules and product/process requirements.
Interfaces directly with Business Unit Managers/Staff Managers to ensure that manufacturing operations and projects receive effective technical support.
Keeps Manager well informed of all major problems, improvement activities and potential barriers.
Performs a variety of other related duties assigned by Engineering Manager.
Represents Ethicon Company during internal, J&J Corporate and FDA audits.
High degree of initiative required resolving unusual processing problems. Must be proactive and exercise good planning to accomplish Department and Company goals.
Develops business cases for new technology introduction and provides input to the plant’s technology strategy.
Owns a technology platform, and may be required to represent the plant in multisite forums.
Responsible for communicating business related issues or opportunities to next management level
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
QualificationsEXPERIENCE AND EDUCATION
Bachelor Science (BS) Degree or Equivalents Bachelor’s degree in Engineering Discipline.
Medical Device experience required
Computer and database management skills
Excellent verbal and written communication skills
Excellence communication and interpersonal relation skills
Experience with Microsoft Project is preferred.
Experience with Minitab is preferred
Experience in leading and managing projects and milestones preferred.
Desire practical, first-hand experience successfully applying lean manufacturing tools with documented improvement project completion.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
Prefer Six Sigma Green Belt or Black Belt certification or equivalent.
Statistical and analytical problem solving
Knowledge of 21CFR 820, 21 CFR 4 and ISO 13485/EN ISO 13485.
Knowledge of Statistical and analytical problem-solving methodologies.
Prefer knowledge of lean manufacturing and manufacturing processes.
Knowledge of SPC, DOE, computer skills (word processing, database, graphical data presentation).
Knowledge of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs).
Training in Process Excellence/Six Sigma tools and methodologies and Certification preferred.
Current Certified Engineer, preferred.
Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
Ability to initiate and manage change as well as build effective teams across manufacturing and support areas in multiple facilities.
ADDITIONAL POSITION REQUIREMENTS
Perform other work-related duties as assigned by supervisor/manager
Works within a team environment; behaving in a CREDO-based, respectful manner.
Complies with all federally regulated programs.
Adheres to J&J environmental and safety policies and guidelines.
Complies with all job specific safety procedures and utilize PPE when necessary.
Complies with quality system requirements as defined within procedures and instructions.
Utilizes applicable software systems as needed for the job (e.g. ComplianceWire, ADAPTIV, etc.)
Supports LEAN, Six Sigma, and 6S Initiatives.
Support Manufacturing Equipment Excellence (ME2) including 6S and Operator Asset Care.
Accurately completes records as defined within the job procedures (e.g. manual and/or electronic documentation).
Consistently meet required Training due date targets.
Execute change and design control in accordance with ETHICON procedures
Participate in formulating quality/performance standards or product/processes.
Support efforts to develop and sustain a culture of waste reduction and affect an ongoing and sustained improvement in product and process quality.
Ensure fulfillment of all regulatory, safety, industrial hygiene and environmental requirements for implementation of new products, processes, and equipment.
Assist in preparation of annual budget, including identification of new projects to drive growth and cost control for both enterprise and operating company success.
Originate Capital appropriation Requests (CAR) for capital required project work.
Fulfill all business plan and CAR obligations for assigned areas of responsibility.
Drive identification and successfully implement cost improvement projects (CIP).
Plan, conduct, and direct validation studies, including complete projects requiring advanced knowledge of equipment and processes.
Coordinate activity of suppliers and divisional contacts within the company.
Accountable for ensuring the completeness of training programs for craft associates on equipment modifications and new machinery in areas of responsibility.
Accountable for assuring product and equipment designs are capable of meeting ETHICON, Inc. quality standards.
Accountable to the Johnson and Johnson Standards of Leadership (Credo Values, customer/Marketplace Focus, Innovation, Masters complexity, and Organizational and People Development)
Investigate and manage customer complaints, as necessary.
RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
Mentor various contractors, co-ops, and/ or new engineers to help them be successful and accomplish department objectives.
Work with outside vendors, machinists and tool makers to complete required work to accomplish objectives and resolve issues
Report directly to applicable Engineering Manager and Manager of Engineering
Work closely with applicable business unit to resolve issues and support objectives
Complete Instructor led Training as needed to ensure work force is adequately trained
Work with training department to ensure all training is documented properly.
Work with work force and applicable business unit to complete validation activities.
Work with inside and outside resources to procure, install, and validate equipment and processes.
Support Engineering manager as needed to serve as designated approver and representative when manager is out of office.
Conduct departmental tours through area of expertise as needed.
o Tours may consist of other J&J colleagues, managers, auditors, guests, etc.
Work with Quality Assurance, SQM, Turtle and Hughes, finance, e-Marketplace, accounts payable, shipping, receiving, EHS&S, and other areas of the plant as needed to meet objectives and resolve applicable issues
Participate in Management Review and CAPA (DRA) meetings as needed.
Manage Instantis deliverables for assigned projects
Participate and or lead ad hoc and regularly scheduled conference (Skype) calls to support applicable projects.
Actively support JJPS project activities as needed
Provide support for timely resolution of NC and CAPA issues.
LOCATION & TRAVEL REQUIREMENTS
This position may support one or more sites in the Ethicon Franchise
Limited travel of up to 10% - 20% may be required to support business needs
EXTERNAL INTERACTIONS
This position may interact with external auditors and Government Agencies as needed.
The anticipated base pay range for this position is $91,000 to $147,200.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. ·Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits:
o Vacation – up to 120 hours per calendar yearo Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearo Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.This job posting is anticipated to close on 12/3/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.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.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.Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies. Attracting, developing, and retaining a workforce that reflects the diversity of our customers and communities is essential to our success. We are committed to providing a respectful, inclusive, and accessible work environment where all employees can achieve their potential.