Senior Package Development Engineer – Orthopedics

Jobtailor; Massachusetts; On-site; USD 110,000 - 135,000; Full time

Job summary

Jobtailor in United States, Massachusetts, seeks a seasoned packaging engineer to lead regulatory submissions and oversee packaging design documentation for notified bodies. You will ensure robust, compliant packaging solutions align with evolving customer needs.

The role requires 4–6 years in packaging, experience with ISO13485/11607, ISTA and ASTM, and strong project management. You will mentor teammates and coordinate cross-functional initiatives in a regulated environment.

Qualifications

• Bachelor’s degree in engineering or equivalent required.
• 4–6 years related packaging experience.
• Experience in a regulated environment.
• Experience in packaging qualification or laboratory testing.
• Familiarity with ISO13485, ISO11607, ISTA and ASTM preferred.
• Strong project management skills.
• Experience communicating with internal and external partners including vendors.
• DOE, GR&R, IQ/OQ/PQ, Fishbone methods experience required.

Responsibilities

• Participates in internal and external audits and provides technical expertise for risk assessments and compliance programs.
• Owns submissions of Packaging Design Documentation to notified bodies.
• Delivers robust, compliant packaging solutions meeting customer needs.
• Maintains technical responsibility for interpreting and coordinating assignments.
• Leads troubleshooting of packaging-related issues in manufacturing and the field.
• Develops recommendations on packaging guidelines and standards.
• Oversees issue management to ensure compliant problem resolution.
• Keeps up-to-date with industry and regulatory trends and translates them to practice.
• Adheres to laws and policies, maintaining professionalism and ethics.

Skills

Audits & compliance

Cross-functional collaboration

Project management

Regulatory knowledge

Packaging standards understanding

Education

Bachelor’s degree in engineering or equivalent

Tools

MINITAB

Job description

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.

Requirements

• Bachelor’s degree in engineering or equivalent Technical Degree or equivalent experience required.
• 4 – 6 years related experience
• Experience in the packaging industry
• Experience in packaging qualification or laboratory testing
• Experience in a regulated environment
• Demonstrated record of successful project management.
• Knowledge of ISO13485, ISO11607, ISTA and ASTM is preferred
• Application and interpretation of process DOE’s (mini-tab preferred), GR&R, IQ/OQ/PQ, Fishbone, etc. is required
• Demonstrated experience working and communicating with internal and external partners, including vendors and suppliers of direct materials and services