DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Technical Lifecycle Management preferably based in Miami, FL, however remote locations will be considered.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com
The position requires the use of multidisciplinary engineering and supply chain knowledge to assist in the execution of cross-functional projects in support of the company's strategies, goals, objectives, and product portfolio. Uses knowledge of scientific techniques and process excellence to design, develop and validate safe, effective, and efficient processes. Provides technical support to ensure continuity of supply.
Duties & responsibilities
Under general supervision and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:
* Drive the execution of Life Cycle Management projects in a cross-functional setting.
* Work under consultative direction toward predetermined long-range goals.
* Work on unusually complex problems and provides solutions which are highly innovative and ingenious.
* Apply broad scientific and engineering knowledge to the development and improvement of medical device products, associated processes, and manufacturing equipment as well as associated validations.
* Work independently and in cross-functional teams (both internal and external) to determine root cause, develop mitigations and corrective and preventative actions for processes and manufacturing related issues.
* Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
* Generally, operate with latitude and has demonstrated leadership abilities.
* Evaluate manufacturing processes / products and collaborates with R&D, NPI, Sourcing, QA, MFG and Finance teams to lead projects / initiatives to improve quality, productivity and reduce costs.
* Utilize the application of six sigma and lean tools and methodologies.
* Design and develops troubleshooting guides and decision-making matrices to ensure the standard application of methods in the resolution of process/ manufacturing technical issues.
* Provide technical training and guidance to manufacturing and engineering personnel.
* Ensure quality conduct of projects including design, data summary and interpretation, report and manuscript preparation and review compliance to applicable regulations.
* Evaluate progress and results against goals and objectives. Recommends major changes in procedures or objectives.
* Generate written reports and provide technical expertise to related projects.
* Maintain accurate documentation of concepts, designs, drawings, processes, test methods, data analysis and conclusions or rationales.
* Provide technical support for outside suppliers, vendors, and/or consultants as required, inclusive of supplier visits and identification / implementation of process improvements.
* Work out proposals and cost estimates of project/process related costs or cost improvements.
* Provide guidance and work direction to lower level engineers and related project team members.
* Responsible for communicating business related issues or opportunities to next management level
* 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
* A minimum of Bachelor's degree is required.
* An advanced degree in preferred.
* A minimum of 10 years of professional experience is required.
* A highly regulated industry knowledge is required; Medical device industry experience is preferred.
* Previous supervisory experience is preferred.
* Familiarity with ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications as related to medical devices is required.
* Six Sigma Process Excellence knowledge is required with certification at the Black belt level preferred.
* Knowledge in some special processes such as polymer processing (compounding, extrusion, fusing), metal processing (machining, laser cutting, polishing), welding, coil winding, equipment & tool design is required.
* Process automation knowledge for small scale assembly is preferred.
* Knowledge of Design for Manufacturability in plastics, metals and small-scale assembly processes is required.
* Knowledge of financial accounting and analysis methods to assess product standard costs, project values, and capital requirements is required.
* Leadership experience in managing technical relationships with external suppliers and OEMs is required.
* Strong project management skills required (Microsoft Project, FPX and/or other project management tools).
* Supplier development skills
* Strong communication, team building, and cross-functional coordination skills.
The position is preferably based in Miami, FL, however remote locations will be considered and requires up to 25% of travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location
United States-Florida-Miami-6303 Blue Lagoon Drive
Other Locations
North America-United States
Organization
DePuy Synthes Products, Inc (6149)
Job Function
Engineering
Requisition ID
2105907549W
New Brunswick, New Jersey
Johnson & Johnson, together with its subsidiaries, researches and develops, manufactures, and sells various products in the health care field worldwide. It operates in three segments: Consumer, Pharmaceutical, and Medical Devices. The Consumer segment offers baby care products under the JOHNSON’S brand; oral care products under the LISTERINE brand; beauty products under the AVEENO, CLEAN & CLEAR, DABAO, JOHNSON’S Adult, LE PETITE MARSEILLAIS, NEUTROGENA, and OGX brands; over-the-counter medicines, including acetaminophen products under the TYLENOL brand; cold, flu, and allergy products under the SUDAFED brand; allergy products under the BENADRYL and ZYRTEC brands; ibuprofen products under the MOTRIN IB brand; and acid reflux products under the PEPCID brand. This segment also provides women’s health products, such as sanitary pads and tampons under the STAYFREE, CAREFREE, and o.b. brands; wound care products comprising adhesive bandages under the BAND-AID brand; and first aid products under the NEOSPORIN brand.
The Pharmaceutical segment offers products in various therapeutic areas, including immunology, infectious diseases, neuroscience, oncology, pulmonary hypertension, and cardiovascular and metabolic diseases. The Medical Devices segment provides orthopedic products; general surgery, biosurgical, endomechanical, and energy products; electrophysiology products to treat cardiovascular diseases; sterilization and disinfection products to reduce surgical infection; diabetes care products; and vision care products, such as disposable contact lenses and ophthalmic products related to cataract and laser refractive surgery.
The company markets its products to general public, and retail outlets and distributors, as well as distributes directly to wholesalers, hospitals, and health care professionals for prescription use. It has research and collaboration alliance with Morphic Therapeutic. The company was incorporated in 1887 and is based in New Brunswick, New Jersey.