Sr Packaging Engineer
Sr Packaging Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Primary Function of Position:
As part of the Packaging Engineering team the person in this position will work to design and qualify packaging systems for instruments accessories endoscopes and system FRUs across all ISI business units. They will provide leadership and aid in the technical development of junior members of the team.
The work will include designing validating and verifying packaging systems includingbut not limited tothermoform packaging such as Form Fill & Seal trays rigid trays and/or pouch sterile barrier systems custom cartons shippers over shippers and reusable cases as well as identifying appropriate label stock for all products.
Roles and Responsibilities:
- Design and develop bestinclass packaging solutions for sterile and nonsterile medical devices (including Field Replaceable Units (FRUs)) from early concept through commercialization. Support packaging needs from early concept through to endoflife.
- Design packaging solutions that meet both internal and external customer needs.
- Own of all aspects of design verification of the packaging systems to meet design requirements and release to production.
- Collaborate with manufacturing and process engineering to implement packaging designs compatible with a class 8 cleanroom environment.
- Identify new packaging processes to improve efficiencies and reduce costs.
- Develop component specifications inspection plans and packaging protocols/reports to insure that the packaging system performs to requirements.
- Create and manage change requests within the document control system.
- Support qualification of sealing/packaging processes within clean room.
- Manage all projects to ensure that all internal and external packaging compliance requirements have been met and that the product is not on the critical path for launch.
- Set standards within the organization for the packaging requirements needed for ISI products.
- As packaging SME support audits nonconformances and CAPAs as needed.
Qualifications :
Skill/Job Requirements:
- Minimum BS Packaging Engineering Mechanical Engineering Industrial Engineering or applicable technical field.
- At least 8 years of experience in medical device packaging design development and various packaging processes (high volume preferred).
- Has a proven background in packaging dynamics lab equipment including electrodynamic/ hydraulic vibration equipment environmental chambers shock testers compression testers drop testers and monitored drop testing.
- Thorough working knowledge of packaging dynamics various packaging materials and their compatibility with sterilization processes such as but not limited to EtO and Gamma.
- Knowledge of packaging validation and verification requirements under CFR Part 820 ISO11607 part 1 & 2 and applicable ASTM standards. Proven understanding of GMP.
- Proven design and project management skills and ability to manage multiple reusable and/or singleuse disposable (SUD) packaging projects across multiple product lines on time.
- Excellent verbal and written communication skills required to successfully collaborate with crossfunctional teams and effectively communicate at multiple levels in the organization.
- Demonstrate a high level of service while managing a high and varied workload from internal clients and adhering to tight timelines.
- Selfmotivated with an ability to prioritize and multitask effectively in a fastpaced dynamic environment.
- CAD knowledge and experience (ProE or Solidworks ArtiosCAD) preferred.
- Must be able to travel occasionally to vendors subcontractors and ISI Mexico plant
Additional Information :
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19. Details can vary by role.
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID19. Details can vary by role.
Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
EEO and AA Policy
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide marketcompetitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target salary ranges are listed.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
