Sign upLog in

Engineering II, Packaging

Integra LifeSciences

Columbia, MD

Apply
JOB DETAILS
SALARY
$71,300–$97,750 Per Year
SKILLS
Analysis Skills, Code of Federal Regulations, Computer Skills, Construction, Continuous Improvement, Cross-Functional, Data Analysis, Design Verification, Documentation, Ergonomics, Establish Priorities, FDA (Food and Drug Administration), GLP (Good Laboratory Practices), Healthcare, Healthcare Providers, ISO (International Organization for Standardization), Industry Standards, Lift/Move 50 Pounds, Machine Tool, Manufacturing, Manufacturing Methods, Medical Equipment, Microsoft Excel, Microsoft Project, Microsoft Visio, Microsoft Word, OSHA, Organizational Skills, Physical Demands, Presentation/Verbal Skills, Process Development, Process Validation, Product Packaging, Product/Service Launch, Production Support, Project Tracking, Project/Program Management, Protocol Design, Quality Assurance Methodology, Record Keeping, Regulations, Reporting Skills, Requirements Management, Research & Development (R&D), Resume Search, Risk Analysis, Root Cause Analysis, Standards of Care, Statistics, Sustainability, System Validation, Technical Writing, Test Data, Test Design, Test Plan/Schedule, Testing, Tissue Engineering, United States Department of Energy (DOE), Usability Engineering, Validation Testing, Variance Analysis, Willing to Travel, Writing Skills
LOCATION
Columbia, MD
POSTED
30+ days ago
Changing lives. Building Careers.


Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.


Reporting to a Manager of Packaging Engineering for Tissue Technologies, this successful individual will take an individual contributor role with packaging projects and possess the ability to influence with multi-functional, high performing teams in a fast-paced environment. This individual will be responsible for specifications, documentation, and package testing in support of New Production Introduction (NPI), Sustaining, and Continuous Improvement projects.


PACKAGING DEVELOPMENT


+ Responsible for the planning, design, development, validation, and improvement of package systems for sterile and non-sterile medical devices with a focus towards innovation, sustainability and usability that align with team and company objectives.


+ Responsible for ensuring medical device packaging meets or exceeds requirements for end user functionality, safety, manufacturability, regulatory, sustainability and business and program objectives.

+ Establishes design requirements, performance, and business criteria through collaboration with health care providers, internal cross functional groups, program management and packaging team members.

+ Work as the lead packaging engineer by collaborating with R&D, Quality, Regulatory, Labeling, Operations, suppliers, and others, to design, develop, validate, and implement package systems from exploratory through product commercialization.

+ Proven independent technical team member. This includes but is not limited to knowledge of project management skills, ability to coordinate with cross-functional teams, technical knowledge of various medical grade material and suppliers, use of design and manufacturing methodologies, risk analysis, testing method development, and package system validation.


TOOLING AND EQUIPMENT:


+ Shall assist in developing packaging concepts using internal and external resources.

+ Understanding of ergonomics as related to repetitive stress injuries.

+ Define and track project tooling and equipment schedule and cost.


VERIFICATION AND VALIDATION:


+ Experience in generating test plans, writing protocols, conducting design verification/validation, and processing validation for package testing is required.

+ Executes package testing and maintains complete records of packaging process and equipment design activities, test data, and other pertinent information for each project.

+ Able to define statistical sample sizes as related to variable and attribute data, based on established company and industry standards.

+ Responsible for developing detailed process qualification strategies, Process Characterization, IQ, OQ, and PQ for packaging equipment.

+ Complete data analysis, identify root causes, draw conclusions, and generate reports that present sound data driven conclusions.

+ Perform other duties as assigned.


DESIRED MINIMUM QUALIFICATIONS


+ Bachelor's degree in Packaging Engineering or a related Science field, advanced degree is preferred.

+ 3-5 years of experience, an M.S. degree with 2 years of experience; a Ph.D. with 1 years of experience or comparable in-depth knowledge of materials and processes used in construction and manufacturing of medical device packaging (thermoform tray, pouches, operation of sealing equipment, etc.) is required.

+ Authorized to work in the United States


Required Knowledge, Skills, and Abilities


+ Solid understanding of a broad spectrum of packaging materials, structures, components, and related conversion processes is required.

+ Knowledge of FDA, ISO, ASTM, and ISTA requirements related to packaging and labeling, and how to apply them is required. Standards include, at minimum, ISO 11607 Parts 1 and 2, ISO 13487, ISO 14971, FDA 21 CFR part 820.

+ Generate detailed specifications using GD&T methodologies.

+ Ability to prioritize multiple rapidly changing priorities with minimal direction is required.


+ General knowledge of statistical analysis i.e., DOE, ANOVA, Capability Analysis, Histograms, Normality Test.


+ Strong technical writing/documentation skills are preferred.

+ Elevated level of written and verbal communications skills.

+ Proficient PC skills (MS Word, MS Excel, MS Project, MS Visio).


Travel Requirements


+ Travel as needed 15% - 25% (domestic and international)


Physical Requirements


+ Ability to sit for extended periods

+ Ability to work on computer for extended periods

+ Ability to lift and carry 50 lbs.

+ Ability to work in a mechanical laboratory environment, including meeting OSHA and cGLP requirements.


Position is located in our Columbia, MD facility (hybrid - 3 days)


Salary Pay Range:


$71,300.00 - $97,750.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training . In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation . Your recruiter can share more about the specific salary range for your preferred location during the hiring process.


Additional Description for Pay Transparency:


Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).


Subject to the terms of their respective policies and date of hire, Employees are eligible for the following https://jobs.integralife.com/total-rewards/


Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.


This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)


Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.


Unsolicited Agency Submission


Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.


Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)

About the Company

I

Integra LifeSciences