Are you looking to work with a lively and diverse team?
Are you looking for a company that offers amazing benefits?
Would you love to work for a company that makes a difference in the lives of mothers & babies every day?
Please go to https://www.medela.com/company/medelacares to learn about us.
The Sr. Manufacturing Project Engineer (Plastic/Silicone Molding/Tooling SME) position is located at Medela's US-based manufacturing and development facility headquartered in McHenry, Illinois. www.medela.com
What We Offer our Sr. Manufacturing Project Engineer (Plastic/Silicone Molding/Tooling SME):
Excellent salary and bonus potential
Comprehensive benefits plan, which is affordable to our employees
401K with match
Fully funded Pension Plan
16-week paid parental leave
Generous PTO package, including 14 paid holidays
Medela is seeking a Sr. Manufacturing Project Engineer (Plastic/Silicone Molding/Tooling SME) who has experience in injection molding and plastic engineering, preferably in medical device molding. In this role you will coordinate and execute the molding efforts on new program launches, set up and/or revise manufacturing processes, and support the Global Supplier Development Team in problem-solving and continuous improvements. The Supplier Development Engineer will furthermore be responsible for the injection molding qualification (IQ, OQ, PQ) activities of legacy and new molded components, addressing customer feedback issues, implementing process improvements on existing processes, and implementing cost improvement ideas.
Position Responsibilities:
Develop and install new injection molding equipment and document all implementation processes for molded products.
Develop and improve molding processes for new and existing products.
Analyze and monitor manufacturing processes and data, suggest improvements, and maintain optimization of equipment.
Establish the parameters for an optimal molding environment and ensure the quality output of molded components.
Review, evaluate, and manage First Article Inspection Reports (FAIR).
Execute injection molding process validation activities (IQ, OQ, PQ) for new and existing components and collect data for reporting.
Complete PQ reports transferring products into ongoing production.
Provide production support to external suppliers.
Assist with developing and implementing Quality Procedures, Standard Operating Procedures and other manufacturing-related documentation.
Prepare specifications for plastic processes and execute gages to maintain optimal quality and assist in designing control plans.
Review product and mold designs during the realization of molding tools and evaluate mold-filling simulations.
Prepare requests for project funding and monitor spending against budget through the completion of the project.
Support investigation of customer complaints and initiate action to prevent the recurrence of non-conformities related to the product, processes, or the quality system.
Manage cost requests, establish manufacturing costs and equipment, and maintain knowledge of safety regulations for various processes.
Provide support to develop plastic tools for injection molding equipment and perform root cause analysis for injection molding processes.
Identify and review improvement initiatives to maintain product quality, perform required tests, and validate manufacturing processes.
Administer projects and recommend improvements to facilitate first-time quality.
Perform regular investigations and ensure optimizations for projects.
Education/Experience Requirements:
BS or MS in Plastics, Tooling, or Mechanical Engineering (or equivalent scientific qualification). MS degree in Engineering preferred.
5+ years of relevant working experience in injection molding and plastic engineering is required, preferably in medical device molding.
Experience in Research and Development, Manufacturing Operations, and Quality related environments, preferably in a regulated environment (healthcare, medical device industry).
Previous experience in plastic part design and development, tool making, and tool design is desired.
Experience in Design of Experiments (DoE), injection molding process validation (IQ, OQ, PQ), and scientific molding procedures, preferably of medical equipment/ devices.
Experience in 3D CAD applications and interpretation of plastic injection molding simulation software tools (e. g. Moldflow or Moldex3D) is desired.
Experience in project work, problem-solving techniques, analytical and structured approaches, and teamwork.
Experience working and collaborating with suppliers regarding technical aspects, quality, costs, and timing in injection molding and plastics/ rubber processing.
Experience in a healthcare, medical device, or government-related environment desired.
Understanding and familiarity with ISO 13485, FDA 21 CFR Part 820, GDP requirements, and other international standards (e. g. MDR).
This is not a job description. More details will be provided regarding the functions of the Sr. Manufacturing Project Engineer (Plastic/Silicone Molding/Tooling SME) position.
Caring has always guided everything we do at Medela. As a family company, you could even say it’s in our DNA. Over the last 60 years, our company has been devoted to the science of making the most delicate form of care simple, intuitive, and effective. Across different stages of life, our products go beyond form and function. They heal, nurture health, and build bonds – building better outcomes through equal parts physics, compassion, engineering, and humanity. And we have been caring for moms and babies, patients, and healthcare professionals for so long, we’ve turned it into a science.
As an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, citizenship, sex, protected veteran status, age, physical or mental disability, medical condition, HIV/AIDs status, marital status, domestic partner status, sexual orientation, gender identity (transgender status), weight, height or any other characteristic protected by federal, state, or local law or ordinance.
