Packaging Engineer

Packaging Engineer Brooksource - 3.7 Santa Clara, CA Job Details Contract $65 - $75 an hour 4 days ago Benefits Health savings account Paid holidays Health insurance Dental insurance Flexible spending account Paid time off Employee assistance program Vision insurance 401(k) matching Qualifications Microsoft Word Bachelor's degree in mechanical engineering Statistics Microsoft Excel Engineering testing Hypothesis testing ISO standards 5 years Labeling Engineering Regulatory compliance Bachelor's degree in biomedical engineering Mechanical Engineering Six Sigma methodology implementation Engineering process optimization Biomedical Engineering English GMP Mid-level Printing Master's degree Minitab Six Sigma Bachelor's degree in engineering Bachelor's degree Continuous improvement SolidWorks Design controls Manufacturing Engineering FMEA Quality systems Document management Cross-functional collaboration Implementing cost-saving initiatives Environmental management systems Implementing lean manufacturing processes Process engineering FDA regulations Statistical analysis tools Engineering validation Full Job Description Packaging Engineer Santa Clara, CA (onsite 5 days a week) Contract through end of year (potential to convert or extend) $70-75/hr

Job Details:

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview Senior Packaging Engineer is responsible for supporting packaging and labeling processes for established product lines. Essential Job Functions Work collaboratively with Production departments, QA and R D to modify package configuration, conduct package transit test, be able to write package specification, QA NCRs, Per PLM documentation and implement required label and package structure changes. Select, procure, install, and validate sealing machines and labeling equipments Assist in conducting manufacturing Process FMEAs Identify and implement packaging/labeling process improvement and cost rationalization projects. Support development and testing of a wide variety of package configurations. Tests may include materials aging studies, preconditioning, and transit testing using industry test standards, like

ASTM D4169.

Develop packaging engineering specifications document based on product fragility and in accordance with cost considerations, regulatory requirements, and type of product protection requirements. Develop and maintain documentation for design control, product configurations, manufacturing procedures, history records, (e.g., bills-of-materials, MPI's, LHR's), and other Quality System requirements Create and manage engineering change requests (ECO) change justification within the document control system. Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology. Support all JNJ packaging initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Perform other related duties and responsibilities, on occasion, as assigned. Requirements Bachelor's degree in Packaging Engineering, Manufacturing Engineering or Engineering discipline (Mechanical, Biomedical, etc.) Familiar and experience with packaging materials including polymeric and cellulose based materials. Minimum of five (5) years of experience in packaging, printing and label creation. Overall years of experience 7+ (Preferred) Visa required Advance English read and write skills Knowledge of compliance with applicable Quality System requirements such as QSRs, FDA, ISO 11607, MDR, MDSAP and EU packaging requirements. Familiarity with Microsoft Excel, Power Point and MS Word Knowledge of documentation management and understanding of Good Manufacturing Practices (GMPs). Experience with Packaging Validation of Medical Devices (IQ-OQ-PQ), ASTM D4169. Experience with manufacturing lean thinking and Lean 6 Sigma concepts. Experience in Statistics (Cpk, Hypothesis Testing, DOE, Gage R&R) a plus. Ability to use special software such as: SolidWorks, Minitab and palletization software or closely related design and statistical software. Ability to work in a fast-paced environment while managing multiple priorities. Operate as a team and/or independently while demonstrating flexibility to changing requirements. Employee may be required to occasionally lift objects up to 25lbs.

Disclaimer:

Brooksource, Medasource, and Calculated Hire are part of the Eight Eleven Group family of companies and operate under Eight Eleven Group, LLC. All employees receive the same benefits, policies, and terms of employment.

EEO:

We are committed to creating an inclusive environment for all employees and applicants. We do not discriminate on the basis of race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, military or veteran status, citizenship, pregnancy (including childbirth, lactation, and related conditions), or any other protected status in accordance with applicable federal, state, and local laws.

Benefits & Perks:

Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee's needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

Pay:

$65.00 - $75.00 per hour

Benefits:

Dental insurance Health insurance Vision insurance Application Question(s): Are you local to Santa Clara, California? Are you open to contract to hire roles? Do you have experience in Med Device or Pharma as

Packaging Engineer Work Location:

In person