Group Leader - Medical Device Testing
SUMMARY OF FUNCTIONS:
The Group Leader/Packaging Engineer Testing is responsible for leading laboratory personnel and overseeing the planning and execution of physical package testing, device testing, and thermal qualification studies. This role ensures timely and accurate delivery of testing services aligned with client requirements, company standards, and regulatory guidelines. required by customer needs.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Lead and manage laboratory staff fostering a cultures of performance, accountability and development.
- Oversee client contracts and proposals, ensuring alignment with service capabilities and objectives.
- Plan, manage, and execute complex or multi-phase projects using technical expertise and strategic foresight.
- Establish departmental goals and ensure alignment with site priorities.
- Act as a technical consultant to support the commercial team and contribute to business growth.
- Represent the department during client visits and contribute to marketing initiatives including blogs, marketing campaigns, and press releases.
- Provide tools, guidance, and opportunities to support employee growth and career development.
- Identify and implement cost-saving initiatives and laboratory efficiencies.
- Initiate/Review of Change Controls, Deviations, & CAPAs as required.
- Ensure compliant handling and documentation of controlled substances within the laboratory.
- Verify client and sample data, test methods, and specifications for accuracy and completeness.
- Prepare test protocols, test methods, technical documents and final reports as required.
- Assist metrology with the maintenance and operation of laboratory equipment, instruments and logbooks including calibrations, performance verification and equipment IQ/OQ/PQ.
- Ensure compliance with laboratory policies and procedures.
- Maintain a strong working knowledge of industry-standard methods, troubleshooting techniques, and regulatory background relevant to testing activities.
ORGANIZATIONAL RELATIONSHIPS:
Reports to the Senior Director, Site Lead
EDUCATIONAL OR SKILL REQUIREMENTS:
- BS degree in Package Engineering, Mechanical Engineering or Engineering Sciences or equivalent laboratory experience.
- 3-5 years of relevant experience in a GMP environment, Required
- ASTM D4169 testing experience, Preferred
- ISTA experience, Preferred
- Leadership experience, Preferred
- LIMS experience , Preferred
- Proven project management capabilities with a demonstrated ability to lead complex projects.
- Strong intrapersonal and leadership skills; ability to work with cross functional teams.
- A self-motivated and proactive personality with ambitions deliver within a fast-paced, employee empowered environment
- Excellent communication, written, math, and organizational skills.
- Knowledge of lab quality systems, cGMPs, and document control processes required.
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