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Packaging Engineer II - Waltham, United States - Physiol
Description
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Job Details:
Packaging Engineer II
Full details of the job.
Job Requisition Name
Packaging Engineer II
Job Requisition No
VN7884
Work Location Name
USA - Waltham
Worker Basis
Full Time
Worker Type
Employee
Applications Close Date
Company
BVI is refocusing the future of vision.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver (Knives and Blades), Visitec (Cannulas), Malosa (Single-Use Instruments), Vitreq (Vitreoretinal Surgical Products) and PhysIOL (Premium IOLs), and spans more than 90 countries.
We've set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye.
Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs.
We trust and empower our associates to make decisions and solve problems because collaboration drives us.Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more atPurpose
The Packaging Engineer II is responsible for managing and executing packaging changes, developing and analyzing packaging, products, materials, processes and equipment for projects of moderate complexity for high impact Research & Development initiatives including BVI's EUMDR program, new product development, value improvement, and sustaining (commercial) engineering projects.
Works with project teams on packaging, product design and development, materials testing, specification preparation, process capability studies, report preparation as well as documentation processes and tests from concept to commercialization while adhering to medical device design controls/regulatory requirements.
Performs engineering analyses to support new and existing designs.
Compile, analyze and report operational, test, and research data to establish performance standards for newly-designed or modified packaging, products, processes or materials.
Fabricates prototypes with internal and external suppliers.Works with internal and external manufacturing partners to support packaging activities and testing.
Effectively communicates activity status, issues and mitigation plans with key stakeholders.
Completes packaging tests of new sustainable materials for product development.
Work independently to plan and schedule activities necessary to meet timelines.
Keep abreast of new technologies and advances in the medical device packaging industry
Other duties as required.
Qualification
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Possesses sufficient engineering acumen required to support technical activities such as running engineering tests, performing biocompatibility on packaging, assessing
sterilization impacts , and coordinating and generating testing protocols.
Knowledge of ISO 11607 part I & part II, EUMDR Regulation (EU) 2017/745 , and cGMP's requirements.
Working knowledge of packaging equipment for all related processes, ISTA, ISO, and ASTM standards.
Experience in sustainability and process improvement initiatives
Knowledge of Microsoft Office's suite of products.
Excellent communication skills, both written and verbal.
Ability to independently lead technical assessment(s), generating, and documenting test plans and reports.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Ability to manage multiple priorities simultaneously.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in Packaging or related field, and minimum three (3) years' relevant experience; or equivalent combination of education, training and experience.
Experience serving as the program manager for cross functional project teams in the end-to-end lifecycle bring new products/technologies from concept through commercialization.
Experience operating in regulated design controls environment a plus.PHYSICAL REQUIREMENTS
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting and standing for extended periods of time.
Bending, squatting, and lifting up to 30 lbs.
May require travel up to 20%.
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