Olympus America Inc. Packaging Engineer II in Southborough, Massachusetts
Southborough, MA - The Packaging Engineer II will provide technical packaging support in the areas of design and process development, testing, and scale-up of new packaging systems and processes. He/she participates on cross-functional engineering assignments and provides technical packaging support to OSTA for new product and process development, manufacturing, and sustaining engineering activities.
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
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Plan and execute key package engineering assignments related to new product development, manufacturing, and sustaining activities.
Engage in packaging projects related to process development, cost saving initiatives, innovative package design, equipment standardization, and test method development.
Determine and coordinate performance and stability testing to ensure product and package integrity for design and manufacturing through the end-user.
Lead troubleshooting efforts for the resolution of packaging related issues for design, manufacturing, and in the field.
Make recommendations on packaging improvements for design, processing, and functional requirements and assists with the implementation activities.
Execute packaging projects and support in compliance with government and corporate guidelines.
Participate in risk assessment and compliance assurance programs for packaging.
Assure delivery of fully compliant packaging solutions that meet current customers’ needs.
Create packaging design requirements; such as component prints, assembly prints, and inspection criteria.
Assist in developing packaging processes including all elements of process validation.
Create, review, and approve internal packaging verification and validation documentation.
Lead and/or support continuous improvement measures by providing technical information and reviewing packaging designs and processes as they are revised.
Train operators, supervisors and other employees on use of new packaging designs, testing, equipment and/or processes.
Know and follow all laws and policies that apply to one's job while maintaining the highest levels of professionalism, ethics and compliance at all times.
*Perform all other essential duties as required.
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
Bachelor's degree in science, engineering or technology discipline is required; a packaging engineering degree is desired.
Minimum of 2 years of professional experience within the medical device industry supporting packaging is required.
The ideal candidate is desired to have a successful record of supporting packaging design and process development on new product development teams.
Experience working in integrated cross-functional product development teams is essential.
Experience developing packaging for new product development is desired.
Process development and/or manufacturing experience is necessary.
Base understanding of ISO 11607-1/2 and how it guides requirements for packaging design, process development, manufacturing, and testing is essential.
Knowledge of sterile packaging design, material characteristics, and verification/validation practices is necessary.
Must be able to support multiple project teams simultaneously.
Demonstrated experience in executing design verification and/or process validation of packaging in the medical device industry; including technical writing of protocols and reports is essential.
Experience in writing and executing design verifications and/or process validations is essential.
Knowledge of and understanding of ISO13485 and its application to medical device products is desired.
Basic statistical analysis and Design of Experiments (DOE) knowledge is desired.
Must possess an understanding of risk analysis and exposure to design and process FMEAs.
The candidate must be proficient with the use of Microsoft Office applications.
Must possess time management skills allowing for working on multiple projects at once.
Auto req ID 2942BR
Posting Title Packaging Engineer II
Company URL Gyrus ACMI at http://www.gyrusacmi.com/
About Us Olympus Surgical Technology America is a dynamic medical device company whose vision is to anticipate the needs of surgeons through powerful see and treat procedure solutions that are safe, simple, cost efficient and produce the highest quality patient outcomes. Olympus Surgical Technology America is focused on Minimally Invasive procedures in Urology, Gynecology, General Surgery and ENT. Olympus Surgical Technology America believes its people are its greatest asset. We offer an environment that challenges everyone to grow, contribute, excel and share successes. Olympus Surgical Technology America is committed to creating a world class company with world class people. Gyrus ACMI at http://www.gyrusacmi.com/
Posting Locations Massachusetts, Southborough
Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.