
Staff Package Development Engineer – Orthopedics, Trauma
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Florida • Massachusetts • United States
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Salary
💰 $94,000 - $151,800 per year
Job Level
About the role
- 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.
Requirements
- Bachelor’s degree in engineering or equivalent Technical Degree or equivalent experience required.
- 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
Benefits
- Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
- Eligible to participate in the Company’s long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
packaging design documentationqualification testinglaboratory testingFMEACAPANCtechnical writingregulatory compliancerisk assessmentsissue management
Soft Skills
leadershipmentoringcommunicationproblem-solvingcross-functional networkingorganizational skillsproject managementteam collaborationprofessionalismethics
Certifications
Bachelor’s degree in engineeringTechnical Degree