Sr. Manager, Packaging Engineering – Endologix – Irvine, CA, USA
Endologix develops and manufactures minimally invasive treatments for aortic disorders. We offer a dynamic, growth environment, competitive compensation and benefits, and a challenging, fulfilling experience in a fast-paced, growing company. Medical device professionals have the opportunity to develop and further their careers in a dynamic company that features the latest innovations in endovascular aneurysm repair and sealing.
Manages the packaging engineering staff and support services. Manages and participates in the design and scale-up of packaging and support services through pilot plant and manufacturing scale. Manages all Labeling related projects and labeling specialist staff.
- Hands on leadership and execution of all packaging engineering activities.
- Package design, development, validation and implementation
- Technical ownership of the companies packaging and labeling equipment and systems.
- Partner with Quality Engineering on the testing and validation of all new / changed packages.
- Coordinate with Production and Supply Chain to implement new packages and/or new packaging/labeling equipment
- Management of the packaging staff to support all company goals and objectives
- Leadership and coordination of all Labeling related projects.
- Coordinate cross functional activities (primarily Marketing, Clinical and R&D) to establish content and translation requirements.
- Coordinate cross functional activities to ensure labeling compliance (with Regulatory and Quality Assurance) and compatibility with company systems.
- Manage external service providers (i.e. Translation) to ensure on time, on budget execution.
- Lead/coordinate execution of implementation activities for new or updated labeling.
- Documentation & Drafting Services
- Lead direct report(s), contracted resources and other assigned internal resources to execute technical product documentation (drafting, modeling, procedures, etc.) to support project completion per timelines.
- Identify and implement best practices.
- Support company goals and objectives, policies and procedures, and FDA regulations
- Continually assess the Packaging, Labeling and related procedures for continual improvement. Implement system improvements as needed.
- Packaging and Labeling SME during quality internal and external audits
- Responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
- In accordance with Endologix’s policies and applicable laws and regulations: Select, reward, discipline, train and develop employees.
- Plan and direct performance of staff members as assigned: Motivate employees, assist in goal setting, provide development opportunities and performance feedback, address complaints and resolve problems. Ensure compliance with internal policies and external legislation/regulations.
- Perform other duties as assigned by supervisor.
- Experience with catheter and interventional delivery system packaging is required.
- Preferred experience to include; Cold Chain, GS1 Compliance, RFID and sterilization methods (EtO, VHP, Gamma and E-Beam)
- Must be familiar with medical device labeling control and software.
- Strong background in process/product validation.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
- Has the ability to use statistic techniques when analyzing data and make rational and logical decisions based on that analysis.
- Applicable knowledge of Minitab, JMP, or other statistic tools.
- Applicable knowledge of Solidworks or other CAD software (not a requirement but a desirable skill).
- Ability to handle multiple tasks simultaneously and ability to manage project timelines
- Bachelor’s degree in a scientific/engineering discipline required. Master’s degree desired
- Minimum of 12 years of experience with a Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years of experience; or equivalent combination of education and experience in medical devices preferably implantable medical devices.
Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.