Staff Package Development Engineer

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Job Description:

Johnson & Johnson is searching for the best talent for a Staff Package Development Engineer (Orthopedics - Trauma) to be located in West Chester PA.

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 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 customers 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 ones 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 establishedand evolving regulatory and company requirements

Education Requirements:

Bachelors 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

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

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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