Johnson & Johnson is searching for the best talent for a Staff Package Development Engineer (Orthopedics - Trauma) to be primarily located in Zuchwil, Switzerland , with consideration of other J&J offices or remote. Remote work options may be considered on a case-by-case basis and if approved by the Company.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

US - Requisition Number: R-060771

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Position Duties and Responsibilities 

• Participates in internal and external Audits and provides technical expertise for risk assessments and compliance assurance programs. Ownership of submissions of Packaging Design Documentation to notified bodies

• Assures delivery of robust, cost effective, fully compliant packaging solutions that meet current and evolving customer's needs.

• Has full technical responsibility for interpreting, organizing, executing and coordinating assignments.

• Leads troubleshooting in the resolution of packaging related issues in manufacturing and the field. Develops recommendations on general packaging guidelines and standards for processes and functional requirements.

• Oversees issue management with technical responsibility to ensure problems are solved in a compliant and effective manner and ensure our organization reaches high levels of efficiency.

• Maintains up to date knowledge of the industry and regulatory trends and standards related to packaging and ensures these are translated into working practices.

• Knows and follows all laws and policies that apply to one's job, and maintains the highest levels of professionalism, ethics and compliance at all times.

• Subject matter expert for packaging department (job function dependent) and is responsible for internal and external audits.

• Serve as a mentor for other team members and may supervise direct reports

• Internal cross functional networking and external benchmarking of new technologies, materials, solutions and suppliers

• Evaluates the validation approach and strategy to ensure continuous improvement consistent with established and evolving regulatory and company requirements

Education Requirements:

·  Bachelor’s degree in engineering or equivalent Technical Degree or equivalent experience required. 

Experience:

·       6 – 8 years related experience

·       Proven track record in the packaging industry

·       Experience responding to notified bodies and Health Authorities

·       Proven track record in qualification or laboratory testing

·       Experience in regulated industry

·       Experience strategizing and leading projects

·       Knowledge of ISO13485, ISO11607, ISTA and ASTM is preferred

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·       Demonstrated experience working and communicating with internal and external partners, including vendors and suppliers of direct materials and services

·       Excellent technical writing skills and understanding required to include and approve protocols, engineering studies, procedures, project status & special reports

·       Experience in engineering activities such as FMEA, CAPA, and NC required

Interpersonal skills/ characteristics (if applicable)

·       Team player

·       Advanced problem-solving Skills

·       Creative

·       Self-starter and independent worker

·       Strategic thinker

·       Leadership mentality