- Provide leadership and direction to the Packaging Engineering team to accomplish all team goals and objectives.
- Maintain staff by recruiting, selecting, and training employees; maintain a safe, secure, and legal work environment.
- Manage team development through training, coaching and career mapping; develop personal growth opportunities.
- Work cross-functionally on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Provide consultation to other departments and sites requiring packaging specific guidance.
- Acquire and maintain a clear understanding of the technologies utilized in Illumina’s products, parts, and services.
- Provide guidance around the design and selection of primary, secondary and tertiary packaging components and suppliers.
- Provide guidance regarding technical protocols and reports for primary, secondary and tertiary packaging components and associated qualifications and/or validations.
- Interface with internal teams and external suppliers to conduct packaging testing (including shipping validations) of packaging materials and packaged components.
- Create and implement applicable procedures and work instructions for development aspects of packaging.
- Oversee technical personnel as directed or requested.
- Perform other duties as assigned by the department manager.
- All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities
Requirements and Education:
- Requires a Bachelors, Masters or PhD. in Packaging Engineering or related discipline.
- Ideal candidate will have a minimum of 8years industrialexperience, with a minimum of 3 years in a FDA and ISO regulated environment desired.
- Requires a minimum of 2 years management experience.
- Demonstrated ability to execute, lead teams and influence organizational change.
- Experienceapplying quality regulations and standards (21CFR 820, ISO 13485, ISO 14971, IVDD) is required.
- Experience writing and executing validation protocols and reports for packaging equipment and processes.
- Strong statistical, data analysis and root cause investigation skills required.
- Highly effective communication, facilitation, negotiation and teamwork skills are required
- Excellent interpersonal, written, and verbal communication skills.
- Adaptable to fast-paced, dynamic work environment with shifting demands.
- Diagnostic industry experiencepreferred.
- Experience with quality and process improvement methodologies and tools (Lean, Six Sigma, value stream mapping, FMEAs, DMAIC) is desired